Randomized clinical trial to assess the effectiveness and tolerability of Mela B3 serum in combination with 35% glycolic acid peel vs. 35% glycolic acid peel for the treatment of various hyperpigmentation conditions (melasma, post-inflammatory hyperpigmentation and solar lentigo) and signs of aging in a population of participants from the Autonomous City of Buenos Aires, Argentina.
Interventional, monocentric, randomized, parallel-group, full-face clinical trial to analyze the effect of MB3 serum in combination with GAP 35 vs. GAP 35 alone. * Group A: GAP 35 on Day0 + post-peel * Group B: MB3 serum from Day-15 to Day84 + GAP 35 on D0 + post-peel Duration: 99 days Visits: Day-15, Day0, Day28, Day56, Day84 (5 visits) Evaluations: * To evaluate the occurrence and severity of post-procedure pigmentation changes, including the development or worsening of PIHP, melasma and solar lentigo, following treatment with MB3 serum and GAP35 determined by change in mMASI, PAHPI socre and SL score. * To demonstrate the effectiveness of MB3 serum in combination (pre- and post-treatment) with GAP 35 in the treatment of the signs of skin aging: * Fine lines and wrinkles * Pores * Skin smoothness * Skin tone, evenness and luminosity * Skin firmness and elasticity * Skin flaccidity * To assess the tolerability of MB3 serum in combination with GAP 35 * To evaluate the quality of life of subjects using QOL (quality of Life) questionnaires * To evaluate the satisfaction of the participants with MB3 serum and cosmeticity using patient satisfaction questionnaire and cosmeticity questionnaire. * To evaluate the changes in skin pigmentation using colorimeter measurements in areas affected by melasma, PIH and SL before and after treatment with MB3 serum and GAP35. * To illustrate the efficacy of the treatment determined by using VISIA imaging.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
80
Glycolic acid peeling 35% at Baseline
Application of a serum MelaB3
Efficacy on hyperpigmentation severity
To demonstrate the effectiveness of Mela B3 serum (MB3 serum) in combination (before and after treatment) with 35% glycolic acid peel (GAP 35) compared to 35% glycolic acid peel alone in the treatment of hyperpigmentation in three conditions: melasma, post-inflammatory hyperpigmentation (PIHP) and solar lentigo (SL) over 3 months' usage when compared to baseline determined by IGA, mMASI, PAHPI and Solar lentigo score.
Time frame: Day-15, Day0, Day28, Day56, Day84
Efficacy on Signs of Anti-ageing
Using a Visual Analogical scale from 0 to 10 for each parameter: * Fine lines and wrinkles * Pores * Skin smoothness * Skin tone, evenness and luminosity * Skin firmness and elasticity
Time frame: Day-15, Day0, Day28, Day56, Day84
Local Tolerance
Clinical signs (erythema, dryness, and desquamation) assessed by Investigator Symptoms of local skin irritation (itching, tingling, and burning sensation) will be assessed by the patient using 5-level scoring scales from 0 to 3 (0/ 0,5 / 1/ 2/ 3): No signs of irritation (no erythema/dryness/desquamation) 0 Doubtful signs of irritation (doubtful erythema/dryness/desquamation) 0.5 Mild signs of irritation (mild erythema/dryness/desquamation) 1 Moderate signs of irritation (moderate erythema/dryness/desquamation) 2 Severe signs of irritation (severe erythema/dryness/desquamation) 3
Time frame: Day-15, Day0, Day28, Day56, Day84
Quality of Life (Dermatology Life Quality Index - DLQI)
DLQI questionnaire : Ten questions about the impact of skin disease on quality of life over the last week. Each question is scored on a four-point Likert scale: * Very much = 3 * A lot = 2 * A little = 1 * Not at all = 0 * Not relevant = 0 * Question unanswered = 0 * Question 7, 'prevented work or studying' scored 3 The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Time frame: Day-15, Day28, Day84
Instrumental assessment - Colorimetric measurement with Chromameter
Instrumental assessment with Chromemeter Colorimetric measurements will be performed at each assessment visit in accordance with the study site's Standard Operating Procedures (SOPs). Three (3) areas will be assessed: Affected Exposed Area: average of 2 facial lesions with a diameter greater than 2 mm. Unaffected Exposed Area: Average of 2 distinct areas. Unaffected Unexposed Area: One single area (buttock area or inner arm). Skin color will be measured using a portable computer-controlled colorimeter Chromameter® CR 400 (Konica-Minolta, Osaka, Japan), using the L\*a\*b\* color space, where: * L\* represents luminosity (L\* = 0 corresponds to black and L\* = 100 indicates diffuse white), * a\* indicates the position between green and red (negative values indicate green, and positive values indicate red), * b\* indicates the position between blue and yellow (negative values indicate blue, and positive values indicate yellow).
Time frame: Day-15, Day0, Day28, Day56, Day84
Stigmatization questionnaire (Patient Unique Stigmatization Holistic tool -PUSH-D)
This questionnaire refers to the last 4 weeks. 17 questions. All of the claims are related to your skin condition. It is important that you answer each one spontaneously, based on what you feel or perceive. If any statement does not fit your reality at all, mark "Not applicable". Frequency 4 Very often 3 Often 2 Sometimes 1 Rarely 0 Never
Time frame: Day-15, Day 28, Day 84
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