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.
Women and men
From 30 to 70 years of age (inclusive)
Good general health
With any type of phototype
Pregnant, breastfeeding or with pregnancy plans.
All contraindications for superficial peeling (for example, concomitant infectious processes or inflammatory processes that affect the skin barrier).
Melasma with predominance of the pigmentary component at the dermis level, observed with Wood's light at the inclusion visit.
Active acne with 10 or more inflammatory lesions.
Parallel
Glycolic acid peel alone
Procedure/SurgeryGlycolic acid peeling 35% at Baseline
MelaB3 serum
Other interventionApplication 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.
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
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
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.
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).
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