Promius Pharma, LLC., an affiliate of Dr. Reddy’s Laboratories, recently announced the results of a pilot study to estimate the efficacy and tolerability of Promiseb Cream when applied topically twice daily for up to 14 days in pediatric patients with cradle cap, or seborrheic dermatitis.
The multicenter, double-blind, placebo-controlled study evaluated the efficacy and safety of Promiseb Cream for cradle cap. The parent/caregiver applied Promiseb Cream or Eucerin Cream (placebo cream) twice daily, approximately every 12 hours to the patient’s head for a minimum of 7 days and for up to a maximum of 14 days. If the cradle cap was considered resolved (clear) at the day 7 visit, as determined by the investigator, the study treatment was stopped and the patient was withdrawn from the study as completed. At each visit, the investigator assessed the cradle cap using the 5-point Investigator Global Assessment [IGA] scale. Individual signs of scaling, crusting, erythema and oiliness were graded by the investigator.
Inclusion criteria verified that the patient’s parent/caregiver understood what was expected and was willing to provide consent and adhere to study requirements, that the patients were at least 30 days of age, and that the patients were naïve to any prior topical cradle cap therapy. Prior use of baby oil, olive oil or similar mineral or vegetable oil was acceptable. A total of 42 patients at four sites were enrolled into the study, with 15 patients in the placebo group and 27 in the Promiseb Cream group. Thirty-seven patients (12 in the placebo group and 25 in the Promiseb Cream group) had data after baseline and were included in the efficacy and safety analyses.
In Promiseb Cream treatment group, 96% of patients had IGA success (clear/almost clear) at the end of treatment (day 7 or day 14) compared to 92% in the Eucerin Cream placebo group. There was a significant (p<0.05) reduction and percent reduction from baseline in IGA score at day 7 and end of treatment for both treatments, with no significant difference between treatment groups (p>0.05). There was a significant (p<0.001) reduction from baseline in erythema, scaling, crusting and oiliness scores at day 7, and at day 7 and day 14 for both treatments. There was a statistically significant difference between treatments in the percent reduction of scaling score at the end of treatment, but not for crusting, erythema, or oiliness. In the Promiseb Cream group there was a 90% reduction in scaling score at the end of treatment compared to a 60% reduction for the placebo group (p=0.03). All patients had an overall safety score of excellent.
