Hyperpigmentation, Melasma, Peeling, Solar Lentigo
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREGlycolic acid peel alone
Glycolic acid peeling 35% at Baseline
OTHERMelaB3 serum
Application of a serum MelaB3
Sponsors
Cosmetique Active International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Women and men 2. From 30 to 70 years of age (inclusive) 3. Good general health 4. With any type of phototype 5. Hyperpigmentation condition with average darkness \> 3: 1. Epidermal or mixed melasma (determined by Wood's lamp examination at screening), mild to moderate melasma (IGA 1 or 2) 2. Post acne inflammatory hyperpigmentation (PIHP), mild to moderate (IGA 1 or 2) with no active acne and less than 10 inflammatory lesion on full face 3. Solar lentigo (SL) with a pigmentation score\>5 6. Willingness to protect oneself from the sun as much as possible for the duration of the study 7. Willingness to avoid contraindicated products (irritants, other depigmenting agents) 8. Signing of written informed consent
Exclusion criteria
1. Pregnant, breastfeeding or with pregnancy plans. 2. All contraindications for superficial peeling (for example, concomitant infectious processes or inflammatory processes that affect the skin barrier). 3. Melasma with predominance of the pigmentary component at the dermis level, observed with Wood's light at the inclusion visit. 4. Active acne with 10 or more inflammatory lesions. 5. In the case of melasma, participants with recent change of contraception (less than 3 months) or less than 3 months since childbirth. 6. Participant using irritating products (require a washout period of at least 2 weeks). 7. Use of medications that may induce melasma, such as antiepileptics (requires a washout period of 1 month). 8. Use of other products with depigmenting activity (requires a washout period of 1 month). 9. Other facial dermatoses or known photosensitivity, or a pre-existing or latent dermatologic health condition and/or disease on the face (e.g., psoriasis, rosacea, acne, eczema, seborrheic dermatitis, severe excoriations) that, in the judgment of the investigator, are considered inappropriate for participation or may interfere with study results. 10. Topical treatments applied to the face (requires a 2-week washout period). 11. Scheduled facial procedures during the course of the study. 12. Participants undergoing phototherapy (requires a 1-month washout period). 13. Known hypersensitivity to study products. 14. History of laser resurfacing procedures, intense pulsed light, facial radiofrequency, deep peeling, facial mesotherapy with tranexamic acid, botulinum toxin or dermal filler injections, or cosmetic procedures on the face within 6 months prior to the start of the study. 15. Facial treatment with microdermabrasion within 6 weeks prior to study entry. 16. Persons with visible tanning, scars, moles, excessive hair or other dermal conditions on the face that, in the judgment of the investigator, may influence the results of the study. 17. History of skin cancer, immunosuppression or immunodeficiency disorders (including HIV infection or AIDS), or current use of immunosuppressive drugs. 18. Uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism or hypothyroidism. Persons with multiple health conditions may be excluded, even if controlled by diet or medication. 19. Participation in another clinical trial within one week prior to entering this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy on hyperpigmentation severity | Day-15, Day0, Day28, Day56, Day84 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy on Signs of Anti-ageing | Day-15, Day0, Day28, Day56, Day84 | 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 | Day-15, Day0, Day28, Day56, Day84 | 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) | Day-15, Day28, Day84 | 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 | Day-15, Day0, Day28, Day56, Day84 | 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). |
| Stigmatization questionnaire (Patient Unique Stigmatization Holistic tool -PUSH-D) | Day-15, Day 28, Day 84 | 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 |
Contacts
CONTACTMargot Broallier, Clinical Trial Manager
Outcome results
None listed