Efficacy of Silver-based Gel Compared With Fusidic Acid Cream in Topical Treatment Following Trichloroacetic Acid Facial Skin Peeling: A Pilot Study

Background. Trichloroacetic acid (TCA) is a nontoxic chemical that has been used for more than 20 years in skin rejuvenation treatments for various skin conditions. Currently, there is no single accepted protocol for local burn care following TCA peeling. Objective. This pilot study assesses the efficacy and tolerability of a silver-based gel compared with fusidic acid cream as a complementary topical treatment for burns following TCA peeling. Materials and Methods. The authors conducted a comparative study on healthy female patients in the Department of Plastic and Reconstructive Surgery at Assaf Harofe Medical Center (Zerifin, Israel). Patients were treated with TCA 15% for superficial facial skin peeling, followed by applications of both the silver-based gel and fusidic acid cream on opposite sides of their face. Patient evaluation included high-resolution photographic evaluation pre- and post-peeling; physician assessment for the presence of complications such as infection, edema, and allergic reactions; and a self-completed questionnaire in reference to the outcomes and side effects (eg, burning, itching) experienced. Results. Seventeen women were included in the study. None of the patients experienced an infection or allergic reaction. Photographic analysis found no significant differences in the outcomes between topical treatments, with a trend for better results with the silver-based gel. Pain, edema, and burning sensations were not significantly different between the topical treatments. Itching was less prevalent in the silver-based gel group (P = .046). Conclusions. Comparing between the groups treated with silver-based gel and fusidic acid cream, the authors found no inferiority in the outcomes or the prevalence of any complaints, and a superior effect on the prevention of wound itch using a silver-based gel.

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Trichloroacetic acid (TCA) is a nontoxic chemical that has been used for more than 20 years in skin rejuvenation treatments for various skin conditions, such as acne scars, melasma, sun damage, and other skin diseases.^1-4

Use of low concentrations of TCA (10%–35%) causes a first-degree or superficial second-degree burn to the skin, removing the superficial layers and peeling the skin’s epidermis within a few days of application. This superficial removal prompts the wound healing process to regenerate the skin.^1,2 In common practice, TCA peeling usually is combined with topical antibacterial agents to prevent posttreatment skin infections and alleviate discomfort.⁵ Although infection following chemical peeling is rare,⁶ there are several reports of patients developing toxic shock syndrome after such treatments.⁷ Therefore, the antibacterial topical treatment is primarily aimed against Staphylococcus aureus infections.⁸ A second important function of the topical treatment is relieving some of the discomfort associated with the burn healing process.^5,9

In 2016, the global wound care market was estimated at $18.2 billion,¹⁰ and, naturally, there is a wide variety of ointments, creams, and other topical applications for the treatment of various types of wounds, including burns, ulcers, and abrasions. As is the case for many other types of wounds, there is no single accepted protocol for local burn care following peeling, but physicians often use common anti-staphylococcal agents, such as 2% fusidic acid cream(Fucidin; LEO Pharma, Ballerup, Denmark).^5,11 Agents containing silver ions are known for their antibacterial and anti-inflammatory traits and are in common use in treating wounds as well as first- and second-degree burns.^12,13 Despite their wide use in the treatment of burns, silver-based agents are not commonly used for treating facial skin after peeling.

SilvrSTAT gel (ABL Medical LLC; American Fork, Utah) is a nanosilver-based gel (active ingredients: nanosilver 32 parts/million) commonly used in the treatment of all degrees of pressure ulcers, diabetic ulcers, traumatic wounds (ie, wounds with complete epidermal loss), first- and second-degree burns, and various types of colonized or infected wounds.¹⁴

This pilot study was conducted to assess the efficacy and tolerability of the silver-based gel compared with fusidic acid cream as a topical treatment for burns following TCA peeling. The conclusions from this study will help determine the safety and design of a future larger scale study.

This comparative study was conducted in the Department of Plastic and Reconstructive Surgery at Assaf Harofeh Medical Center (Zerifin, Israel) in April 2017. Inclusion criteria for enrollment in the study included healthy female patients with superficial facial melasma aged 18 to 65 years, with a Fitzpatrick skin type of I to III.

The study protocol received the approval of the Assaf Harofeh Medical Center Institutional Ethics Committee and was held in accordance with the provisions of the Declaration of Helsinki. All participants provided written informed consent for participation in the study prior to study initiation.

All patients were treated with TCA 15% for superficial facial skin peeling by an experienced plastic surgeon. Then, the patients were instructed to apply the silver-based gel and fusidic acid cream to their face, each on a different side of the burn/face, by drawing a theoretical vertical midline dividing the face into 2 sections (right/left). This regimen was performed twice daily over a 2-week period. The decision of which side would be treated with which agent was made randomly. Both the patient and the primary physician knew which agent was being used on which side; however, the evaluating physician, different from the treating physician, was blinded to the treatment regimen on follow-up visits.

Three follow-up visits were held at the authors’ treating outpatient clinic on days 7, 14, and 30 posttreatment (Figure). Evaluation of the patients in each follow-up visit included:

1. Photography of the face, which was conducted before peeling treatment and in each follow-up visit. Photos were evaluated with specific attention to spots, texture, red areas, and porphyrins. This was performed with a high-resolution camera and VISIA Complexion Analysis (Canfield, Scientific, Inc, Parsippany, NJ), which allows immediate automated picture analysis by measuring the exact visual differences between photographs of the same patient (before and after treatment and between follow-up visits). The system evaluated photographs for total spots, brown spots, erythematous plaques, and skin texture.

2. A self-completed questionnaire regarding patient satisfaction with the outcome and side effects (level of itching, burning sensation, pain, and degree of peeling), with a scale for each complaint ranging from none, minor, and moderate to very severe (0–3).

3. Physician assessment for presence of complications (ie, infection, edema, and allergic reactions [yes/no]).

Exclusion criteria for participation consisted of patients who had undergone peeling treatment in the 2 years prior to the study period, had Fitzpatrick skin type IV to VI, had a current herpes infection, had regular isotretinoin use, were pregnant, were current smokers, had previous facial hair removal by laser, did not meet the inclusion criteria, and did not provide informed consent for participation.

Data were compared between facial sides using McNemar’s test or Wilcoxon signed-rank test. All statistical tests were 2-tailed, and P < .05 was considered statistically significant.

Out of 21 women who met inclusion criteria, 17 (34 hemifaces) were included in the study. The mean age was 56.1 years. Fitzpatrick skin type varied from I to III. Patient demographics are presented in Table 1.

There was no evidence of infection or allergic reactions in any patients. The complexion analysis found no significant differences between the sides treated topically with the silver-based gel and fusidic acid cream, with results showing a trend for a greater decrease in the number of total spots (3.9% silver-based gel vs. 2% fusidic acid cream reduction) and brown spots (6.9% silver-based gel vs. 1.3% fusidic acid cream reduction).

There were fewer complaints of itching on the silver-based gel-treated side compared with the fusidic acid cream (12 cases, 70.6% vs. 15 cases, 88.2%; P = .046, respectively).

No significant differences in the other parameters assessed were noted. Edema was seen in 7 cases (41.2%) in the silver-based group versus 5 (29.4%) in the fusidic acid group (P = .157). Complaints of pain were present in 8 cases (47.0%) in the silver-based group compared with 7 (41.2%) in the fusidic acid group (P = .157). In the silver-based gel group, there were 14 cases (82.4%) of burning sensation complaints compared with 15 (88.2%) in the fusidic acid group (P = .564). Side effects and complications are summarized in Table 2.

The current study assessed a silver-based gel as a potential local treatment for superficial burns caused by chemical peeling and compared the results with fusidic acid cream, a commonly used topical care product.

This study found no cases of bacterial infection in either the silver-based gel group or the fusidic acid group. As infections are rare after peeling, this study’s sample size is too small to evaluate a difference between the treatments in infection prevention, but it does indicate no inferiority of the silver-based gel in this regard. Although the outcomes showed no significant differences between topical treatments, there was a trend for a greater reduction in spots in the side treated with the silver-based gel. The authors found no significant differences between the silver-based gel and fusidic acid cream in the prevalence of several common after-effects of peeling: pain (P = .157), edema (P = .157), or burning sensation (P = .564). Itching, one of the most common discomforts following peeling, was found to be significantly less common in the silver-based gel group.

As previously stated, given the nature of the chemical peeling treatment, it is often associated with marked discomfort during the healing process, and an important goal for topical treatment is to relieve this discomfort. These findings show no inferiority for the silver-based gel as compared with fusidic acid cream, and even indicate superiority in regard to itching.

As a pilot study, there is a small sample size, making it hard to reach statistical significance, primarily with regard to rare complications such as infection or allergic reactions. In addition, the patients were not blinded to which side of the face was treated with which treatment product.

This study found no adverse effects in the use of the silver-based gel for topical treatment after chemical peeling. Compared with topical treatment with fusidic acid cream, the authors found no inferiority in the prevalence of any of the complaints and a superior effect in preventing itching. Although it is unclear whether the silver-based gel actually has a positive effect on the cosmetic outcome, at the least it seems to be as good as the commonly accepted treatments currently in use.

While further study with a larger sample size is needed to investigate rare complications and report better statistical validity to the findings herein, the silver-based gel appears to be a safe and effective topical treatment for use after chemical peeling.

Affiliation: Department of Plastic and Reconstructive Surgery, Assaf Harofe Medical Center, Zerifin, Israel

Correspondence: Geva Landau, MD, Assaf Harofeh Medical Center, Department of Plastic and Reconstructive Surgery, 70300 Zrifin, Bear Yacov, zrifin 70300 Israel; gevalandau@gmail.com

Disclosure: The authors’ institution received a grant for the sum of $5000 from ABL Medical (American Fork, UT; manufacturer of study product) toward study expenses, such as medical supplies. The authors disclose no financial or other conflicts of interest.