the Melasma group received three peels, and the Skin of Color group received two peels. The first peel was administered on day 0 and subjects visited the office on day 3 and day 7 to observe the skin’s response. Additional peels were administered at subsequent visits with a final follow-up visit two weeks after the last peel.
Each study visit consisted of dermatologist clinical grading, objective and subjective tolerability grading, digital photography, and self-assessment questionnaires. Dermatologist visual clinical grading was conducted for each group using a modified Griffith’s scale (0=none to 9=severe) and included efficacy grading for fine lines, wrinkles, mottled pigmentation/melasma, pore size, lack of clarity/radiance, laxity, overall global photodamage, and overall global acne evaluation (Acne Subgroup; 0-4 scale). Tolerability was assessed before, during, and 10 minutes postpeel application by the dermatologist (erythema; 0-3 scale) and subject (burning/stinging; 0-3 scale). General objective and subjective irritation were assessed throughout the study by the dermatologist (dryness, erythema, peeling, roughness; 0-3 scale) and subject self-report (burning/stinging, tightness/dryness, and skin sensitivity; 0-3 scale). Days 3 and 7 were included as additional visits to assess tolerability and the skin’s visible response to the peel. Adverse events were recorded and tabulated as a measure of safety. Self-assessment questionnaires were administered to capture subject’s perception of benefits to skin. Standardized digital photography was conducted (VISIACR and Omnia; Canfield Scientific, Inc.) before the first peel, at day 3, day 7, prior to each subsequent peel, and at the final follow-up visit.
Statistics
Primary clinical endpoints included dermatologist visual grading scores of photodamage in the Photodamage group after the series of 4 peels with comparisons to baseline conditions for each subject at each visit. Statistical comparisons were made using the Wilcoxon Signed Rank test and significance was determined at P≤0.05. The Melasma group, Skin of Color group, and Acne Subgroups were included as case studies, and as such, their data was not statistically analyzed due to the small population size of each group. These case studies, however, provide an assessment of the peel across a range of skin types, and thus, offer valuable safety and tolerability data for the peel. Self-assessed benefits to skin were summarized using mean scores. Tolerability was tabulated using mean scores for objective and subjective irritation during the peel. Safety was recorded through adverse event reporting.
Each study visit consisted of dermatologist clinical grading, objective and subjective tolerability grading, digital photography, and self-assessment questionnaires. Dermatologist visual clinical grading was conducted for each group using a modified Griffith’s scale (0=none to 9=severe) and included efficacy grading for fine lines, wrinkles, mottled pigmentation/melasma, pore size, lack of clarity/radiance, laxity, overall global photodamage, and overall global acne evaluation (Acne Subgroup; 0-4 scale). Tolerability was assessed before, during, and 10 minutes postpeel application by the dermatologist (erythema; 0-3 scale) and subject (burning/stinging; 0-3 scale). General objective and subjective irritation were assessed throughout the study by the dermatologist (dryness, erythema, peeling, roughness; 0-3 scale) and subject self-report (burning/stinging, tightness/dryness, and skin sensitivity; 0-3 scale). Days 3 and 7 were included as additional visits to assess tolerability and the skin’s visible response to the peel. Adverse events were recorded and tabulated as a measure of safety. Self-assessment questionnaires were administered to capture subject’s perception of benefits to skin. Standardized digital photography was conducted (VISIACR and Omnia; Canfield Scientific, Inc.) before the first peel, at day 3, day 7, prior to each subsequent peel, and at the final follow-up visit.
Statistics
Primary clinical endpoints included dermatologist visual grading scores of photodamage in the Photodamage group after the series of 4 peels with comparisons to baseline conditions for each subject at each visit. Statistical comparisons were made using the Wilcoxon Signed Rank test and significance was determined at P≤0.05. The Melasma group, Skin of Color group, and Acne Subgroups were included as case studies, and as such, their data was not statistically analyzed due to the small population size of each group. These case studies, however, provide an assessment of the peel across a range of skin types, and thus, offer valuable safety and tolerability data for the peel. Self-assessed benefits to skin were summarized using mean scores. Tolerability was tabulated using mean scores for objective and subjective irritation during the peel. Safety was recorded through adverse event reporting.
RESULTS
Twenty-four subjects completed the study for tolerability and safety endpoints, including 14 subjects in the Photodamage group (inclusive of five subjects in the Acne Subgroup), five subjects in the Melasma group, and five subjects in the Skin of Color group. A total of 78 retinol peels was administered. Tolerability of the 3% retinol peel on the skin showed only 4 instances of mild erythema and 5 instances of mild stinging/burning over the 78 peels. Mean scores for objective and subjective irritation were assessed over the course of the study and were less than or equal to baseline after the series of peels. A visible skin response in the days following the retinol peel was observed by the dermatologist and subjects. Dermatologist visual grading showed up to moderate increases in peeling, dryness, roughness, and erythema by day 3, which decreased or resolved by
