COMPARATIVE EVALUATION OF THE DERMATOLOGICAL TOLERANCE AND EFFICACY OF A COSMETIC SERUM VERSUS A 4% HYDROQUINONE-BASED PRODUCT IN SUBJECTS WITH MELASMA, AFTER 84 DAYS OF USE - STUDY CONDUCTED UNDER DERMATOLOGICAL SUPERVISION
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Modified Melasma Area and Severity Index (mMASI) Score From Baseline (Day 0) to Day 84 ±1 Day, Assessed by a Blinded Dermatologist to Evaluate the Clinical Efficacy of the Investigational and Comparator Products in Subjects With Melasma
研究概览
简要总结
The goal of this clinical trial is to compare the dermatological tolerance and skin-lightening efficacy of a cosmetic depigmenting serum to a 4% hydroquinone-based product in adult male and female subjects aged 18-65 years with mild to moderate epidermal or mixed-type melasma.
The main questions it aims to answer are:
Does the cosmetic serum reduce the severity of melasma (measured by mMASI) after 84 days of use?
Is the cosmetic serum better tolerated than 4% hydroquinone under real-use conditions?
Researchers will compare the serum group and the hydroquinone group to determine whether the cosmetic product achieves comparable pigmentation improvement with superior skin tolerability.
Participants will:
Group 1: Apply a morning routine (Depiwhite Serum + Depiwhite M SPF50+ cream) Apply an evening routine (Depiwhite Serum + Placebo Cream without Hydroquinone)
Group 2: Apply a morning routine (Serum Placebo + Depiwhite M SPF50+ cream) Apply an evening routine (Serum Placebo + Depigmenting Cream with hydroquinone 4%)
Visit the clinical site at baseline (Day 0), Day 56, and Day 84 for assessments
Complete standardized photographs, self-assessment questionnaires, and quality-of-life surveys (MELASQoL and ASLQI)
Undergo clinical evaluations by a dermatologist, including mMASI scoring and tolerance assessment
详细描述
Melasma is a chronic hyperpigmentation disorder of multifactorial origin, often aggravated by ultraviolet (UV) radiation, hormonal changes, and inflammation. It predominantly affects individuals with Fitzpatrick skin phototypes III to V and manifests as irregular brown macules and patches, particularly on sun-exposed facial areas. While 4% hydroquinone remains the gold standard topical agent for melasma, its long-term use is associated with adverse events such as irritant dermatitis and exogenous ochronosis, prompting the development of alternative dermocosmetic formulations.
This double-blind, randomized, controlled trial investigates the comparative efficacy and cutaneous tolerance of an intensive anti-spot cosmetic serum (Depiwhite Serum) versus a hydroquinone 4% cream (Eldopinone), both used in conjunction with a high-protection SPF50+ sunscreen (Depiwhite.M). The serum incorporates a combination of active ingredients designed to target melanogenesis and its upstream mediators through a multi-pathway mechanism, including anti-inflammatory, antioxidant, and melanin-regulatory actions.
The study will evaluate changes in melasma severity using a modified Melasma Area and Severity Index (mMASI) score and standardized facial photography acquired with the ColorFace® imaging system. These photographs will undergo high-resolution colorimetric analysis by QIMA Life Sciences, quantifying pigmentation changes through CIELab parameters (L*, a*, b*), ITA°, and contrast metrics (ΔE76, ΔITA°, etc.), tracked across predefined regions of interest (ROIs) from lesional and perilesional skin.
Additional assessments include subjective product performance evaluation, cosmetic acceptability, and patient-reported outcomes using two validated quality-of-life instruments (MELASQoL and ASLQI). Safety and local tolerance will be monitored at each clinical visit via dermatologist-led skin examinations and subject-reported functional symptoms.
The trial aims to generate robust clinical and instrumental data supporting the use of cosmetic formulations as a potential alternative or maintenance therapy to hydroquinone in melasma management, particularly for populations seeking better tolerability profiles without compromising efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Investigator is: The principal investigator who was masked
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, primarily female, aged 18 to 65 years at the time of inclusion
- •Fitzpatrick skin phototype II to V
- •Diagnosed with mild to moderate epidermal or mixed-type facial melasma, confirmed by Wood's lamp examination
- •mMASI score between 3.5 and 13 at baseline
- •Subject is in general good health as assessed by the investigator based on medical history and clinical examination
- •Willing to avoid excessive sun exposure and use only the provided SPF50+ sunscreen during the study
- •Able to understand the study procedures and provide written informed consent
- •Willing and able to comply with study procedures and scheduled visits
- •Women of childbearing potential must agree to use a reliable method of contraception for at least 3 months prior to and during the entire study duration
排除标准
- •Presence of post-inflammatory hyperpigmentation (PIH), lentigines, or other non-melasma facial pigmentation
- •Use of topical or systemic depigmenting treatments, retinoids, corticosteroids, or hormonal treatments within 4 weeks prior to baseline
- •Known allergy or hypersensitivity to any component of the investigational or comparator products
- •Excessive sun exposure or use of tanning beds within 2 weeks before baseline or planned during the study
- •Active skin diseases (e.g., atopic dermatitis, psoriasis) or damaged skin in the test area
- •Pregnant or breastfeeding women, or those planning to become pregnant during the study
- •Participation in another clinical trial within 4 weeks prior to the study or planned participation in another trial during the study
- •History of malignancy in the past 10 years (except treated basal cell carcinoma)
- •Uncontrolled systemic illness (e.g., diabetes, cardiovascular, hepatic, renal, or pulmonary disease)
- •Any psychological or cognitive condition that would limit the subject's ability to understand the study procedures
- •Current use of photosensitizing medications
- •BMI > 40 or other conditions that may affect protocol compliance as judged by the investigator
研究组 & 干预措施
Depiwhite Serum + Placebo Cream
Subjects apply Depiwhite Serum (morning and evening) with Depiwhite M SPF50+ cream in the morning and a placebo cream (no hydroquinone) in the evening for 84 days.
干预措施: Depigmenting Cosmetic Serum (Applied Morning and Evening) (Drug)
Placebo Serum + Hydroquinone 4% Cream
Subjects apply a placebo serum (morning and evening) with Depiwhite M SPF50+ cream in the morning and hydroquinone 4% cream (Eldopinone) in the evening for 84 days.
干预措施: Depigmenting Cosmetic Serum (Applied Morning and Evening) (Drug)
结局指标
主要结局
Change in Modified Melasma Area and Severity Index (mMASI) Score From Baseline (Day 0) to Day 84 ±1 Day, Assessed by a Blinded Dermatologist to Evaluate the Clinical Efficacy of the Investigational and Comparator Products in Subjects With Melasma
时间窗: Baseline (Day 0) to Day 84 ±1 day. The mMASI score will be assessed at both time points by a blinded dermatologist to evaluate the change in melasma severity over the 12-week treatment period.
The modified Melasma Area and Severity Index (mMASI) is a validated clinical scoring method used to assess the severity and extent of facial melasma. It evaluates four facial regions (forehead, right malar, left malar, and chin) based on the area of involvement and the intensity of pigmentation. Each region contributes proportionally to the total score, which ranges from 0 (no melasma) to 24 (severe melasma). In this study, the mMASI score will be assessed by a blinded dermatologist at baseline (Day 0) and again at Day 84 (±1 day). The primary objective is to quantify the change in mMASI score after 12 weeks of treatment with either the investigational cosmetic serum (Depiwhite Serum) or the comparator product containing hydroquinone 4% (Eldopinone). This outcome will serve as the primary measure of clinical efficacy in reducing melasma severity over the course of the study.
次要结局
- Change in modified Melasma Area Severity Index (mMASI) at Day 56(Day 56)
- Change in Individual Typology Angle (ITA°) from baseline(Day 56 and Day 84)
- Change in Melasma Quality of Life Index (MELASQoL)(Day 56 and Day 84)
- Subject-rated product efficacy and cosmetic acceptability(Day 28, Day 56, and Day 84)
- Investigator-assessed dermatological tolerance(Day 56 and Day 84)
- Subject-reported local intolerance symptoms(Day 56 and Day 84)