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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Efficacy on hyperpigmentation severity
研究概览
简要总结
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.
详细描述
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:
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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.
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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:
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Fine lines and wrinkles
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Pores
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Skin smoothness
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Skin tone, evenness and luminosity
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Skin firmness and elasticity
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Skin flaccidity
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To assess the tolerability of MB3 serum in combination with GAP 35
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To evaluate the quality of life of subjects using QOL (quality of Life) questionnaires
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To evaluate the satisfaction of the participants with MB3 serum and cosmeticity using patient satisfaction questionnaire and cosmeticity questionnaire.
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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.
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To illustrate the efficacy of the treatment determined by using VISIA imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women and men
- •From 30 to 70 years of age (inclusive)
- •Good general health
- •With any type of phototype
- •Hyperpigmentation condition with average darkness > 3:
- •Epidermal or mixed melasma (determined by Wood's lamp examination at screening), mild to moderate melasma (IGA 1 or 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
- •Solar lentigo (SL) with a pigmentation score>5
- •Willingness to protect oneself from the sun as much as possible for the duration of the study
- •Willingness to avoid contraindicated products (irritants, other depigmenting agents)
- •Signing of written informed consent
排除标准
- •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.
- •In the case of melasma, participants with recent change of contraception (less than 3 months) or less than 3 months since childbirth.
- •Participant using irritating products (require a washout period of at least 2 weeks).
- •Use of medications that may induce melasma, such as antiepileptics (requires a washout period of 1 month).
- •Use of other products with depigmenting activity (requires a washout period of 1 month).
- •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.
- •Topical treatments applied to the face (requires a 2-week washout period).
- •Scheduled facial procedures during the course of the study.
- •Participants undergoing phototherapy (requires a 1-month washout period).
- •Known hypersensitivity to study products.
- •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.
- •Facial treatment with microdermabrasion within 6 weeks prior to study entry.
- •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.
- •History of skin cancer, immunosuppression or immunodeficiency disorders (including HIV infection or AIDS), or current use of immunosuppressive drugs.
- •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.
- •Participation in another clinical trial within one week prior to entering this study.
研究组 & 干预措施
Control Group
Peeling Alone
干预措施: Glycolic acid peel alone (Procedure)
MelaB3 serum Group
MelaB3 serum + peeling
干预措施: Glycolic acid peel alone (Procedure)
MelaB3 serum Group
MelaB3 serum + peeling
干预措施: MelaB3 serum (Other)
结局指标
主要结局
Efficacy on hyperpigmentation severity
时间窗: 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.
次要结局
- Efficacy on Signs of Anti-ageing(Day-15, Day0, Day28, Day56, Day84)
- Local Tolerance(Day-15, Day0, Day28, Day56, Day84)
- Quality of Life (Dermatology Life Quality Index - DLQI)(Day-15, Day28, Day84)
- Instrumental assessment - Colorimetric measurement with Chromameter(Day-15, Day0, Day28, Day56, Day84)
- Stigmatization questionnaire (Patient Unique Stigmatization Holistic tool -PUSH-D)(Day-15, Day 28, Day 84)