M elasma, which affects many women of child-bearing age, and some men, is a common, but often under-diagnosed condition. In fact, the American Academy of Dermatology (AAD) estimates that 5 million to 6 million American women have melasma. Effectively treating melasma and post-inflammatory hyperpigmentation conditions are very challenging, as you know. Here’s a look at the latest research into available treatments and therapies for these conditions. A Safe and Effective Treatment Results of Community-Based Study for Melasma Treatment Results of a phase IV, open-label, multi-center, community-based trial found fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma) to be safe and effective for the treatment of facial melasma. For this study, 1,290 patients were evaluated for safety, while 1,260 were evaluated for efficacy. Patients ranged in age from 15 years to 84 years and were 3.6% male and 96% female. Subgroups included: Caucasians (800), African- Americans (130), Asians (94), and patients of Hispanic origin (295). Results of this study were presented at the AAD summer meeting in July. All patients were treated with the cream once a day for 8 weeks and evaluated at baseline, week 4, and week 8 using the melasma area and severity index (MASI) and investigator global assessment of improvement. Patients also completed a quality of life questionnaire at baseline and again at week 8. Results showed that there was significant decrease in the mean MASI score from baseline to week 4 and to week 8 (p=.0001 for both time points). The mean MASI score at baseline was 14.68, at week 4 was 7.38, and at week 8 was 3.64. All races showed a significant decrease in mean MASI scores (see chart at left). According to the investigator global assessment of improvement, 85.7% of patients achieved improvement at week 4, and 82.1% achieved improvement by week 8. Treatment of melasma for this study also showed an improvement in quality of life (QOL). According to the patient survey, after 8 weeks of treatment 64.1% of participants felt less embarrassed or self conscious, 52.4% didn’t have to use as many cosmetics, 60.4% no longer felt old, 56.3% felt they didn’t have to try to hide their skin discoloration, and 61.2% felt more attractive. A New Formulation of a Gold Standard A 12-Week Study Shows Positive Results In an effort to determine the efficacy of a new treatment for melasma and post-inflammatory hyperpigmentation, a 12-week, open-label study was performed. The 19 subjects had to apply a 4% hydroquinone containing sunscreens twice a day, once in the morning and once at night, after washing their faces with an unscented, mild soap, and were evaluated at baseline, week 4, week 8 and week 12. Only 16 patients completed the study. The mean age of subjects was 44.4 years, 89% were female, 68% had melasma and 32% had post-inflammatory hyperpigmentation. Results were presented at the Annual AAD Meeting. Patients were evaluated on disease severity on a scale of 0 to 6 where 0 = none, 1 = 1% to 10% of face affected, 2 = 11% to 20%, 3 = 21% to 30%, 4 = 31% to 40%, 5 = 41% to 50%. They were also evaluated on pigment intensity on a scale of 1 to 4 where 1 = mild, 2 = moderate, 3 = moderately severe, and 4 = severe. Other assessments used were colorimetry, using a narrow-band reflectance spectrophotometer taken from an area of normal coloration and an area of hyperpigmentation at baseline and weeks 4, 8 and 12 (see graph above). Levels of dryness, erythema, oiliness, peeling, burning and pruritus were also assessed, and investigator and patient global response on a scale of 0 to 8 were taken at weeks 4, 8 and 12. Results at week 12 showed a statistically significant reduction in disease severity (p<0.0001) and pigment intensity (p<0.0001). Subject and clinician global scores of pigment improvement increased at each follow-up visit. Improvement was also seen in the colorimetry assessments that revealed a statistically significant decrease in readings occurring at week 4 (p=0.005), and continuing through week 8 (p=0.0002) and through week 12 (p=0.0001). Signs and symptoms of facial irritation were minimal. The 4% hydroquinone formulation tested in this study also contains a tyrosinase inhibitor (Rumex occidentalis extract), co-enzyme Q10, sodium PCA and sunscreens (avobenzone, octinoxate and oxybenzone.) Managing Melasma Treating this Condition in Hispanic Women Results of a single center, open-label study on 15 Hispanic women treated for melasma with 4% hydroquinone, 10% buffered glycolic acid, vitamin C, vitamin E and sunscreen cream (Glyquin) were presented at the AAD meeting in July. Patients underwent twice daily full face application with the cream for 12 weeks and were evaluated at baseline and weeks 4, 8 and 12. All of the patients enrolled in this study had moderate-to- severe bilateral epidermal melasma and significant, symmetrical pigmentation on both sides of the face, easily noticeable from a distance of 3 feet. Patients were otherwise healthy, Hispanic women aged 18 to 50. Using a four-point scale (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe), patients evaluated burning, itching, redness, dryness and peeling, and investigators evaluated erythema, scaling, edema, vesicles, crusting and erosions. Changes in pigmentation were measured with a mexameter, and the MASI was used to evaluate the degree of melasma at baseline and at week 12. Mexameter results demonstrated a significant decrease in the degree of pigmentation after using the cream (p<0.05). Of the 15 patients enrolled, 14 showed improvement. There was also a mean decrease in MASI scores of 64% by week 12 compared to baseline. Most patients (14) developed mild-to-severe erythema by week 12 and eight of the 15 patients required a moisturizer after week 8. Patient and physician evaluation (see chart below) showed moderate, obvious or very marked improvement in all patients and overall melasma decreased to clear or mild in 9 patients. A Look at Photoprotective Qualities of a Hydroquinone Results of Study on a Non-Sunscreen Containing Product To determine the photoprotective effects of hydroquinone, alpha hydroxy acid, antioxidant cream (Lustra), a 3-week study was completed comparing it to a hydroquinone with sunscreen cream (Solaquin Forte) and to no treatment. The study enrolled 12 subjects, three female and eight male Caucasians between the ages of 21 and 54 years with skin types I, II or III. One subject withdrew after four treatments. Patients’ mid-back regions were divided into three areas and marked with permanent ink-pen markers. Topical applications were randomized among the three test sites and a technician administered treatment applications once daily (except Sundays) for 3 weeks. Patients were told to avoid direct exposure to sunlight and also weren’t allowed to use any other topical products on the treatment area. The UVR source used was four, 20-inch fluorescent FS20 bulbs. The bulbs were filtered with a 0.15-mm thick sheet of cellulose acetate to remove UVC radiation. The spectral power distribution of the bulbs used was predominantly within the UVB region (290 nm to 320 nm). The average UBV intensity at the skin level was 0.144 mW/cm2, as measured with a UVB-sensitive photometer (IL443 phototherapy radiometer, International Light, Inc., Newburyport, MA). The minimal erythemal dose (MED) for each patient was determined within 3 days prior to obtaining biopsies by administering a series of timed exposures in 25% increments to an adjoining area of the mid-back. Fifteen minutes after the last application of the test products, a circular area within each of the three treatment sites was exposed to a dose of 1.5 MEDs. About 20 hours after this, technicians obtained a shave biopsy from the irradiated site of each patient. Three biopsies were obtained from each patient (one from each site), for a total of 33 biopsies. The number of sunburn cells were determined in 12 sections for each biopsy and a minimum of 75 high power fields (HPFs) were counted from each, using a magnification of 400X. An average number of sunburn cells per HPF was determined for each specimen. Results showed that the hydroquinone, alpha hydroxy acid, antioxidant cream (96%) and the hydroquinone, sunscreen cream (99%) were both significantly effective at inhibiting the production of sunburn cells. The researchers concluded that the hydroquinone without the sunscreen had photoprotective quality most likely due to its antioxidant components. Treating Skin Types IV-VI Assessing the Use of Cream to Treat Post-Inflammatory Hyperpigmentation Patients with Fitzpatrick skin types IV-VI with clinical diagnosis of post-inflammatory hyperpigmentation of the face or body were evaluated for a study on the safety and efficacy of a 4% hydroquinone, 10% buffered glycolic acid, vitamin C, vitamin E and sunscreen cream (Glyquin). For this study, which was presented at the Annual AAD meeting in July, 35 patients were treated twice a day with the cream for 12 weeks. Patients were evaluated at baseline and weeks 4, 8 and 12 for changes in pigmentation both clinically and with mexameter readings of melanin content and erythema. Clinical grading of irritation for erythema, scaling/peeling, edema, crusting and erosion, and subjective grading of burning, itching, pain and overall irritation were measured on a five-point scale (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe). Patient and physician global severity assessments were also made at each visit on a four-point scale (1 = none, 2 = mild, 3 = moderate, 4 = severe). Improvement from baseline was also rated on a five-point scale by both patient and physician at each visit (resolved, significant improvement, slight improvement, no change or worsening). The mexameter results showed an improvement in PIH using the cream at 4 weeks in 79% of patients and in 100% of patients by week 12. Physician and patient assessments showed an improvement in most patients at 4 weeks, and 89% of patients reported no significant symptoms (see graph). Researchers concluded that the cream demonstrated good-to-excellent efficacy and tolerability after 12 weeks of therapy for post-inflammatory hyperpigmentation in skin types IV-VI.
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Melasma Update
M elasma, which affects many women of child-bearing age, and some men, is a common, but often under-diagnosed condition. In fact, the American Academy of Dermatology (AAD) estimates that 5 million to 6 million American women have melasma. Effectively treating melasma and post-inflammatory hyperpigmentation conditions are very challenging, as you know. Here’s a look at the latest research into available treatments and therapies for these conditions. A Safe and Effective Treatment Results of Community-Based Study for Melasma Treatment Results of a phase IV, open-label, multi-center, community-based trial found fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma) to be safe and effective for the treatment of facial melasma. For this study, 1,290 patients were evaluated for safety, while 1,260 were evaluated for efficacy. Patients ranged in age from 15 years to 84 years and were 3.6% male and 96% female. Subgroups included: Caucasians (800), African- Americans (130), Asians (94), and patients of Hispanic origin (295). Results of this study were presented at the AAD summer meeting in July. All patients were treated with the cream once a day for 8 weeks and evaluated at baseline, week 4, and week 8 using the melasma area and severity index (MASI) and investigator global assessment of improvement. Patients also completed a quality of life questionnaire at baseline and again at week 8. Results showed that there was significant decrease in the mean MASI score from baseline to week 4 and to week 8 (p=.0001 for both time points). The mean MASI score at baseline was 14.68, at week 4 was 7.38, and at week 8 was 3.64. All races showed a significant decrease in mean MASI scores (see chart at left). According to the investigator global assessment of improvement, 85.7% of patients achieved improvement at week 4, and 82.1% achieved improvement by week 8. Treatment of melasma for this study also showed an improvement in quality of life (QOL). According to the patient survey, after 8 weeks of treatment 64.1% of participants felt less embarrassed or self conscious, 52.4% didn’t have to use as many cosmetics, 60.4% no longer felt old, 56.3% felt they didn’t have to try to hide their skin discoloration, and 61.2% felt more attractive. A New Formulation of a Gold Standard A 12-Week Study Shows Positive Results In an effort to determine the efficacy of a new treatment for melasma and post-inflammatory hyperpigmentation, a 12-week, open-label study was performed. The 19 subjects had to apply a 4% hydroquinone containing sunscreens twice a day, once in the morning and once at night, after washing their faces with an unscented, mild soap, and were evaluated at baseline, week 4, week 8 and week 12. Only 16 patients completed the study. The mean age of subjects was 44.4 years, 89% were female, 68% had melasma and 32% had post-inflammatory hyperpigmentation. Results were presented at the Annual AAD Meeting. Patients were evaluated on disease severity on a scale of 0 to 6 where 0 = none, 1 = 1% to 10% of face affected, 2 = 11% to 20%, 3 = 21% to 30%, 4 = 31% to 40%, 5 = 41% to 50%. They were also evaluated on pigment intensity on a scale of 1 to 4 where 1 = mild, 2 = moderate, 3 = moderately severe, and 4 = severe. Other assessments used were colorimetry, using a narrow-band reflectance spectrophotometer taken from an area of normal coloration and an area of hyperpigmentation at baseline and weeks 4, 8 and 12 (see graph above). Levels of dryness, erythema, oiliness, peeling, burning and pruritus were also assessed, and investigator and patient global response on a scale of 0 to 8 were taken at weeks 4, 8 and 12. Results at week 12 showed a statistically significant reduction in disease severity (p<0.0001) and pigment intensity (p<0.0001). Subject and clinician global scores of pigment improvement increased at each follow-up visit. Improvement was also seen in the colorimetry assessments that revealed a statistically significant decrease in readings occurring at week 4 (p=0.005), and continuing through week 8 (p=0.0002) and through week 12 (p=0.0001). Signs and symptoms of facial irritation were minimal. The 4% hydroquinone formulation tested in this study also contains a tyrosinase inhibitor (Rumex occidentalis extract), co-enzyme Q10, sodium PCA and sunscreens (avobenzone, octinoxate and oxybenzone.) Managing Melasma Treating this Condition in Hispanic Women Results of a single center, open-label study on 15 Hispanic women treated for melasma with 4% hydroquinone, 10% buffered glycolic acid, vitamin C, vitamin E and sunscreen cream (Glyquin) were presented at the AAD meeting in July. Patients underwent twice daily full face application with the cream for 12 weeks and were evaluated at baseline and weeks 4, 8 and 12. All of the patients enrolled in this study had moderate-to- severe bilateral epidermal melasma and significant, symmetrical pigmentation on both sides of the face, easily noticeable from a distance of 3 feet. Patients were otherwise healthy, Hispanic women aged 18 to 50. Using a four-point scale (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe), patients evaluated burning, itching, redness, dryness and peeling, and investigators evaluated erythema, scaling, edema, vesicles, crusting and erosions. Changes in pigmentation were measured with a mexameter, and the MASI was used to evaluate the degree of melasma at baseline and at week 12. Mexameter results demonstrated a significant decrease in the degree of pigmentation after using the cream (p<0.05). Of the 15 patients enrolled, 14 showed improvement. There was also a mean decrease in MASI scores of 64% by week 12 compared to baseline. Most patients (14) developed mild-to-severe erythema by week 12 and eight of the 15 patients required a moisturizer after week 8. Patient and physician evaluation (see chart below) showed moderate, obvious or very marked improvement in all patients and overall melasma decreased to clear or mild in 9 patients. A Look at Photoprotective Qualities of a Hydroquinone Results of Study on a Non-Sunscreen Containing Product To determine the photoprotective effects of hydroquinone, alpha hydroxy acid, antioxidant cream (Lustra), a 3-week study was completed comparing it to a hydroquinone with sunscreen cream (Solaquin Forte) and to no treatment. The study enrolled 12 subjects, three female and eight male Caucasians between the ages of 21 and 54 years with skin types I, II or III. One subject withdrew after four treatments. Patients’ mid-back regions were divided into three areas and marked with permanent ink-pen markers. Topical applications were randomized among the three test sites and a technician administered treatment applications once daily (except Sundays) for 3 weeks. Patients were told to avoid direct exposure to sunlight and also weren’t allowed to use any other topical products on the treatment area. The UVR source used was four, 20-inch fluorescent FS20 bulbs. The bulbs were filtered with a 0.15-mm thick sheet of cellulose acetate to remove UVC radiation. The spectral power distribution of the bulbs used was predominantly within the UVB region (290 nm to 320 nm). The average UBV intensity at the skin level was 0.144 mW/cm2, as measured with a UVB-sensitive photometer (IL443 phototherapy radiometer, International Light, Inc., Newburyport, MA). The minimal erythemal dose (MED) for each patient was determined within 3 days prior to obtaining biopsies by administering a series of timed exposures in 25% increments to an adjoining area of the mid-back. Fifteen minutes after the last application of the test products, a circular area within each of the three treatment sites was exposed to a dose of 1.5 MEDs. About 20 hours after this, technicians obtained a shave biopsy from the irradiated site of each patient. Three biopsies were obtained from each patient (one from each site), for a total of 33 biopsies. The number of sunburn cells were determined in 12 sections for each biopsy and a minimum of 75 high power fields (HPFs) were counted from each, using a magnification of 400X. An average number of sunburn cells per HPF was determined for each specimen. Results showed that the hydroquinone, alpha hydroxy acid, antioxidant cream (96%) and the hydroquinone, sunscreen cream (99%) were both significantly effective at inhibiting the production of sunburn cells. The researchers concluded that the hydroquinone without the sunscreen had photoprotective quality most likely due to its antioxidant components. Treating Skin Types IV-VI Assessing the Use of Cream to Treat Post-Inflammatory Hyperpigmentation Patients with Fitzpatrick skin types IV-VI with clinical diagnosis of post-inflammatory hyperpigmentation of the face or body were evaluated for a study on the safety and efficacy of a 4% hydroquinone, 10% buffered glycolic acid, vitamin C, vitamin E and sunscreen cream (Glyquin). For this study, which was presented at the Annual AAD meeting in July, 35 patients were treated twice a day with the cream for 12 weeks. Patients were evaluated at baseline and weeks 4, 8 and 12 for changes in pigmentation both clinically and with mexameter readings of melanin content and erythema. Clinical grading of irritation for erythema, scaling/peeling, edema, crusting and erosion, and subjective grading of burning, itching, pain and overall irritation were measured on a five-point scale (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe). Patient and physician global severity assessments were also made at each visit on a four-point scale (1 = none, 2 = mild, 3 = moderate, 4 = severe). Improvement from baseline was also rated on a five-point scale by both patient and physician at each visit (resolved, significant improvement, slight improvement, no change or worsening). The mexameter results showed an improvement in PIH using the cream at 4 weeks in 79% of patients and in 100% of patients by week 12. Physician and patient assessments showed an improvement in most patients at 4 weeks, and 89% of patients reported no significant symptoms (see graph). Researchers concluded that the cream demonstrated good-to-excellent efficacy and tolerability after 12 weeks of therapy for post-inflammatory hyperpigmentation in skin types IV-VI.
M elasma, which affects many women of child-bearing age, and some men, is a common, but often under-diagnosed condition. In fact, the American Academy of Dermatology (AAD) estimates that 5 million to 6 million American women have melasma. Effectively treating melasma and post-inflammatory hyperpigmentation conditions are very challenging, as you know. Here’s a look at the latest research into available treatments and therapies for these conditions. A Safe and Effective Treatment Results of Community-Based Study for Melasma Treatment Results of a phase IV, open-label, multi-center, community-based trial found fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05% cream (Tri-Luma) to be safe and effective for the treatment of facial melasma. For this study, 1,290 patients were evaluated for safety, while 1,260 were evaluated for efficacy. Patients ranged in age from 15 years to 84 years and were 3.6% male and 96% female. Subgroups included: Caucasians (800), African- Americans (130), Asians (94), and patients of Hispanic origin (295). Results of this study were presented at the AAD summer meeting in July. All patients were treated with the cream once a day for 8 weeks and evaluated at baseline, week 4, and week 8 using the melasma area and severity index (MASI) and investigator global assessment of improvement. Patients also completed a quality of life questionnaire at baseline and again at week 8. Results showed that there was significant decrease in the mean MASI score from baseline to week 4 and to week 8 (p=.0001 for both time points). The mean MASI score at baseline was 14.68, at week 4 was 7.38, and at week 8 was 3.64. All races showed a significant decrease in mean MASI scores (see chart at left). According to the investigator global assessment of improvement, 85.7% of patients achieved improvement at week 4, and 82.1% achieved improvement by week 8. Treatment of melasma for this study also showed an improvement in quality of life (QOL). According to the patient survey, after 8 weeks of treatment 64.1% of participants felt less embarrassed or self conscious, 52.4% didn’t have to use as many cosmetics, 60.4% no longer felt old, 56.3% felt they didn’t have to try to hide their skin discoloration, and 61.2% felt more attractive. A New Formulation of a Gold Standard A 12-Week Study Shows Positive Results In an effort to determine the efficacy of a new treatment for melasma and post-inflammatory hyperpigmentation, a 12-week, open-label study was performed. The 19 subjects had to apply a 4% hydroquinone containing sunscreens twice a day, once in the morning and once at night, after washing their faces with an unscented, mild soap, and were evaluated at baseline, week 4, week 8 and week 12. Only 16 patients completed the study. The mean age of subjects was 44.4 years, 89% were female, 68% had melasma and 32% had post-inflammatory hyperpigmentation. Results were presented at the Annual AAD Meeting. Patients were evaluated on disease severity on a scale of 0 to 6 where 0 = none, 1 = 1% to 10% of face affected, 2 = 11% to 20%, 3 = 21% to 30%, 4 = 31% to 40%, 5 = 41% to 50%. They were also evaluated on pigment intensity on a scale of 1 to 4 where 1 = mild, 2 = moderate, 3 = moderately severe, and 4 = severe. Other assessments used were colorimetry, using a narrow-band reflectance spectrophotometer taken from an area of normal coloration and an area of hyperpigmentation at baseline and weeks 4, 8 and 12 (see graph above). Levels of dryness, erythema, oiliness, peeling, burning and pruritus were also assessed, and investigator and patient global response on a scale of 0 to 8 were taken at weeks 4, 8 and 12. Results at week 12 showed a statistically significant reduction in disease severity (p<0.0001) and pigment intensity (p<0.0001). Subject and clinician global scores of pigment improvement increased at each follow-up visit. Improvement was also seen in the colorimetry assessments that revealed a statistically significant decrease in readings occurring at week 4 (p=0.005), and continuing through week 8 (p=0.0002) and through week 12 (p=0.0001). Signs and symptoms of facial irritation were minimal. The 4% hydroquinone formulation tested in this study also contains a tyrosinase inhibitor (Rumex occidentalis extract), co-enzyme Q10, sodium PCA and sunscreens (avobenzone, octinoxate and oxybenzone.) Managing Melasma Treating this Condition in Hispanic Women Results of a single center, open-label study on 15 Hispanic women treated for melasma with 4% hydroquinone, 10% buffered glycolic acid, vitamin C, vitamin E and sunscreen cream (Glyquin) were presented at the AAD meeting in July. Patients underwent twice daily full face application with the cream for 12 weeks and were evaluated at baseline and weeks 4, 8 and 12. All of the patients enrolled in this study had moderate-to- severe bilateral epidermal melasma and significant, symmetrical pigmentation on both sides of the face, easily noticeable from a distance of 3 feet. Patients were otherwise healthy, Hispanic women aged 18 to 50. Using a four-point scale (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe), patients evaluated burning, itching, redness, dryness and peeling, and investigators evaluated erythema, scaling, edema, vesicles, crusting and erosions. Changes in pigmentation were measured with a mexameter, and the MASI was used to evaluate the degree of melasma at baseline and at week 12. Mexameter results demonstrated a significant decrease in the degree of pigmentation after using the cream (p<0.05). Of the 15 patients enrolled, 14 showed improvement. There was also a mean decrease in MASI scores of 64% by week 12 compared to baseline. Most patients (14) developed mild-to-severe erythema by week 12 and eight of the 15 patients required a moisturizer after week 8. Patient and physician evaluation (see chart below) showed moderate, obvious or very marked improvement in all patients and overall melasma decreased to clear or mild in 9 patients. A Look at Photoprotective Qualities of a Hydroquinone Results of Study on a Non-Sunscreen Containing Product To determine the photoprotective effects of hydroquinone, alpha hydroxy acid, antioxidant cream (Lustra), a 3-week study was completed comparing it to a hydroquinone with sunscreen cream (Solaquin Forte) and to no treatment. The study enrolled 12 subjects, three female and eight male Caucasians between the ages of 21 and 54 years with skin types I, II or III. One subject withdrew after four treatments. Patients’ mid-back regions were divided into three areas and marked with permanent ink-pen markers. Topical applications were randomized among the three test sites and a technician administered treatment applications once daily (except Sundays) for 3 weeks. Patients were told to avoid direct exposure to sunlight and also weren’t allowed to use any other topical products on the treatment area. The UVR source used was four, 20-inch fluorescent FS20 bulbs. The bulbs were filtered with a 0.15-mm thick sheet of cellulose acetate to remove UVC radiation. The spectral power distribution of the bulbs used was predominantly within the UVB region (290 nm to 320 nm). The average UBV intensity at the skin level was 0.144 mW/cm2, as measured with a UVB-sensitive photometer (IL443 phototherapy radiometer, International Light, Inc., Newburyport, MA). The minimal erythemal dose (MED) for each patient was determined within 3 days prior to obtaining biopsies by administering a series of timed exposures in 25% increments to an adjoining area of the mid-back. Fifteen minutes after the last application of the test products, a circular area within each of the three treatment sites was exposed to a dose of 1.5 MEDs. About 20 hours after this, technicians obtained a shave biopsy from the irradiated site of each patient. Three biopsies were obtained from each patient (one from each site), for a total of 33 biopsies. The number of sunburn cells were determined in 12 sections for each biopsy and a minimum of 75 high power fields (HPFs) were counted from each, using a magnification of 400X. An average number of sunburn cells per HPF was determined for each specimen. Results showed that the hydroquinone, alpha hydroxy acid, antioxidant cream (96%) and the hydroquinone, sunscreen cream (99%) were both significantly effective at inhibiting the production of sunburn cells. The researchers concluded that the hydroquinone without the sunscreen had photoprotective quality most likely due to its antioxidant components. Treating Skin Types IV-VI Assessing the Use of Cream to Treat Post-Inflammatory Hyperpigmentation Patients with Fitzpatrick skin types IV-VI with clinical diagnosis of post-inflammatory hyperpigmentation of the face or body were evaluated for a study on the safety and efficacy of a 4% hydroquinone, 10% buffered glycolic acid, vitamin C, vitamin E and sunscreen cream (Glyquin). For this study, which was presented at the Annual AAD meeting in July, 35 patients were treated twice a day with the cream for 12 weeks. Patients were evaluated at baseline and weeks 4, 8 and 12 for changes in pigmentation both clinically and with mexameter readings of melanin content and erythema. Clinical grading of irritation for erythema, scaling/peeling, edema, crusting and erosion, and subjective grading of burning, itching, pain and overall irritation were measured on a five-point scale (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe). Patient and physician global severity assessments were also made at each visit on a four-point scale (1 = none, 2 = mild, 3 = moderate, 4 = severe). Improvement from baseline was also rated on a five-point scale by both patient and physician at each visit (resolved, significant improvement, slight improvement, no change or worsening). The mexameter results showed an improvement in PIH using the cream at 4 weeks in 79% of patients and in 100% of patients by week 12. Physician and patient assessments showed an improvement in most patients at 4 weeks, and 89% of patients reported no significant symptoms (see graph). Researchers concluded that the cream demonstrated good-to-excellent efficacy and tolerability after 12 weeks of therapy for post-inflammatory hyperpigmentation in skin types IV-VI.
