Evaluation of the Efficacy of a Cosmetic Product for the Reduction of Facial Hyperpigmentation: A Clinical, Subjective, and Instrumental Study
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 Facial Hyperpigmentation Assessed by Chromameter (L* Parameter)
研究概览
简要总结
This is a single-center, single-blind clinical study designed to evaluate the efficacy of a depigmenting gel cream through clinical, subjective, and instrumental assessments. A total of 40 female participants, aged 30 to 60 years, will be enrolled and followed for 90 days while using the study product.Participants will be assigned to one of two groups. Group I will include 20 participants with facial hyperpigmentation, including post-inflammatory hyperpigmentation and solar lentigines, representing Fitzpatrick skin phototypes I to VI, with at least one participant from each phototype. Group II will include 20 participants with moderate or greater melasma, as assessed by the modified Melasma Area and Severity Index (mMASI), representing Fitzpatrick skin phototypes II to V.
The study aims to evaluate the product's effectiveness in reducing facial hyperpigmentation and improving skin appearance over the treatment period.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female participants aged 30 to 60 years.
- •Group I: Participants with Fitzpatrick skin phototypes I to VI, with at least one participant from each phototype category. Participants with facial hyperpigmentation, including post-inflammatory hyperpigmentation and solar lentigines.
- •Group II: Participants with moderate or greater melasma, as assessed by the modified Melasma Area and Severity Index (mMASI), and Fitzpatrick skin phototypes II to V.
- •Willingness to comply with all study procedures and attend scheduled on-site visits and assessments.
- •Willingness to comply with study procedures and be available for remote contact (telehealth) at scheduled times.
- •Ability to understand the study requirements, provide written informed consent, and sign the informed consent form.
排除标准
- •Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study.
- •Use of anti-inflammatory, immunosuppressive, or antihistamine medications within 3 weeks prior to screening.
- •Skin conditions or marks in the study area that may interfere with the evaluation of skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn.
- •History of atopic conditions or allergy to cosmetic products.
- •Active skin diseases and/or lesions in the assessment area.
- •Immunosuppression due to medication use or active disease.
- •Uncontrolled endocrine disorders.
- •Relevant medical history or current evidence of alcohol or substance abuse.
- •Known history or suspected intolerance to products of the same category as the study product.
- •Intense sun exposure within 15 days prior to assessment.
- •Aesthetic or dermatological treatments within 4 weeks prior to assessment.
- •Any other condition that, in the investigator's opinion, may interfere with study participation or justify exclusion from the study.
研究组 & 干预措施
Facial Hyperpigmentation Group
Female participants aged 30 to 60 years with facial hyperpigmentation, including post-inflammatory hyperpigmentation and solar lentigines, Fitzpatrick skin phototypes I to VI, with at least one participant from each phototype. Participants will use the depigmenting gel cream for 90 days.
干预措施: Blancy Pro (Other)
Melasma Group
Female participants aged 30 to 60 years with moderate or greater melasma, as assessed by the modified Melasma Area and Severity Index (mMASI), Fitzpatrick skin phototypes II to V. Participants will use the depigmenting gel cream for 90 days.
干预措施: Blancy Pro (Other)
结局指标
主要结局
Change in Facial Hyperpigmentation Assessed by Chromameter (L* Parameter)
时间窗: Baseline (Day 0), Day 30, Day 60, and Day 90
Evaluation of the efficacy of the investigational product in improving facial hyperpigmentation in participants with post-inflammatory hyperpigmentation, solar lentigines, and melasma through colorimetric measurements obtained using the Chromameter® device. Changes in the L\* parameter will be assessed over time, with higher values indicating skin lightening.
次要结局
- Change in the Number of Facial Pigmented Lesions Assessed by VISIA® Imaging System(Baseline (Day 0), Day 30, Day 60, and Day 90)
- Change in Facial Skin Tone Uniformity Assessed by VISIA® Image Analysis(Baseline (Day 0), Day 30, Day 60, and Day 90)
- Change in Facial Skin Hydration Assessed by Corneometer®(Baseline (Day 0), Day 30, Day 60, and Day 90)
- Maintenance of Skin pH Assessed by Skin pHmeter®(Baseline (Day 0), Day 30, Day 60, and Day 90)
- Maintenance of Skin Barrier Function Assessed by Tewameter®(Baseline (Day 0), Day 30, Day 60, and Day 90)
- Safety of the Investigational Product Under Normal Conditions of Use(Day 30, Day 60, and Day 90)
- Clinical Improvement of Facial Hyperpigmentation Assessed by a 5-Point Scale(Baseline (Day 0), Day 30, Day 60, and Day 90)
- Change in Melasma Severity Assessed by the Modified Melasma Area and Severity Index (mMASI)(Baseline (Day 0), Day 30, Day 60, and Day 90)
- Participant-Perceived Efficacy and Product Performance Assessed by Subjective Questionnaire(Day 14, Day 30, Day 60, and Day 90)
- Change in Quality of Life Assessed by the MelasQoL Questionnaire(Baseline (Day 0), Day 30, Day 60, and Day 90)