A randomized, controlled study to evaluate the efficacy and tolerability of Eucerin® Anti-Pigment regimen as an adjunctive treatment for melasma before and after non-ablative LASER therapy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- •Change in mMASI and IGA scores at all time points after treatment using Eucerin® Anti-Pigment regimen and non-ablative LASER therapy (ALMA ClearSkin Er:Glass 1540nm) when compared to baseline(TB1 and TB2).
研究概览
简要总结
Melasma is a common skin condition characterized by the appearance of dark, irregular patches, primarily on the face. This dermatological study is an interventional, randomized controlled trial designed to compare the efficacy and tolerability of a new depigmenting cosmetic formulation for managing facial hyperpigmentation (melasma) over a 12-week period, with a total of 8 study visits.
Participants will be informed about the study design and treatment plan and will have sufficient time to review the informed consent form (ICF). The dermatologist will assess the severity of melasma using the mMASI scale and determine the type of melasma. Eligible subjects will be selected based on the inclusion and exclusion criteria. Participants will be instructed to wash their face with the provided facewash and cclimatize for 10 minutes. After this, baseline assessments will be conducted, and test regimens, along with a subject diary, will be provided. Similar assessments will be repeated at baseline 2, 4 days after baseline2, week 2, week 4, week 8 and week 12. LASER therapy will be performed on Baseline 2 and week 4. At the conclusion of the study, the test regimens and subject diaries will be collected, and participants will be asked to complete the study exit form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female subjects aged between 18-50 years (both ages inclusive)
- •Fitzpatrick skin phototype III to VI.
- •Subjects presenting with moderate to severe melasma (based on IGA) and intention to treat.
- •Subjects who have not used any depigmenting agent or undergone any melasma treatment in the past 4-6 weeks as per dermatologists’ discretion.
- •Subjects willing to stop all other skin care products usage on the test site and diligently follow the provided treatment plan.
- •Subject free of excessive hair, cuts, abrasions, fissures, wounds, lacera-tions, or any other skin conditions on the face.
- •Subjects who agree not to use any other product/treatment/home remedy/ except the provided products on their face during the study period.
- •Subjects who agree not to carry out bleaching or any other procedures in-cluding facial etc.
- •on face during the study period.
- •Subjects who agree not to expose to excessive sun light.
- •(Sun exposure not more than half an hour daily and during that time use of an umbrella to cover face).
- •Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
- •Subjects willing to abide by and comply with the study protocol.
排除标准
- •Subject with any other signs of significant local irritation or skin disease.
- •Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study.
- •Subjects on hormonal therapy (contraceptive, TSH) for at least 6 months prior to the study.
- •Subjects who are pregnant/ nursing (self-declared) or have plans of becoming pregnant during the study.
- •Pregnancy in subjects of child bearing potential will be confirmed by urine pregnancy test.
- •Subjects who recently had a skin-lightening procedure in the past 8 weeks or oral photosensitizers or who underwent phototherapy in the past 1 month wash out.
- •Subjects using corticosteroids or under antiepileptic medications for the previous six months.
- •Subjects with a history of any other dermatosis of the face or known photo-sensitivity or undergoing topical treatment with sun protection factor in the past 1 month.
- •Subjects who are exposed to the sun on a regular basis, frequent tanning salons or foresee exposure to the sun during the study or any facial procedure planned during the course of the study,
- •Subjects who have participated in any other clinical trial in the last 3 months.
- •Subjects with inadequate language proficiency (spoken and written).
- •Subject’s inability to be placed in the photography system.
- •Subjects with severe psychological illness or intellectual inability to understand the study.
- •Employees of the CRO or the Sponsor.
结局指标
主要结局
•Change in mMASI and IGA scores at all time points after treatment using Eucerin® Anti-Pigment regimen and non-ablative LASER therapy (ALMA ClearSkin Er:Glass 1540nm) when compared to baseline(TB1 and TB2).
时间窗: baseline 1, baseline 2, 4 days after baseline 2, week 2, week 4, week 8, week 12
•Change in the appearance of melasma using dermatological visual grading scores at all time points after treatment using Eucerin® Anti-Pigment regimen and non-ablative LASER therapy (ALMA ClearSkin Er:Glass 1540nm) when compared to baseline (TB1 and TB2).
时间窗: baseline 1, baseline 2, 4 days after baseline 2, week 2, week 4, week 8, week 12
•Change in the appearance of melasma using VISIA CR at all time points after treatment using Eucerin® Anti-Pigment regimen and non-ablative LASER therapy (ALMA ClearSkin Er:Glass 1540nm) when compared to baseline (TB1 and TB2).
时间窗: baseline 1, baseline 2, 4 days after baseline 2, week 2, week 4, week 8, week 12
•percentage change from baseline based on Spectrophotometer L for pigmentation.
时间窗: baseline 1, baseline 2, 4 days after baseline 2, week 2, week 4, week 8, week 12
次要结局
- •Change in mMASI and IGA scores at all time points before and after treatment using Eucerin® Anti-Pigment regimen and non-ablative LASER therapy (ALMA ClearSkin Er:Glass 1540nm) when compared to control.(•Change in the appearance of melasma using dermatological visual grading scores at all time points before and after treatment using Eucerin® Anti-Pigment regimen and non-ablative LASER therapy (ALMA ClearSkin Er:Glass 1540nm) when compared to control.)
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd.