Comparative Study of Test Product and Cysteamine 5% in Treating Facial Epidermal Melasma
- Conditions
- Health Condition 1: L814- Other melanin hyperpigmentation
- Registration Number
- CTRI/2023/10/058259
- Lead Sponsor
- a Roche-Posay Laboratoire Dermatologique
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Adult subjects in general good health as determined from a recent medical history, general physical examination, dermatological assessment.
2. Subjects of Phototype III, IV, V,
3. Subjects diagnosed with facial epidermal Melasma (exclude mixed and dermal melasma) for more than 1 year.
4. Subjects who have not used contraindicated products (irritants, other depigmenting agents) in the past 4-24 weeks (as per the treatment category, as per dermatologists’ discretion,
5. Subjects willing to stop all other skin care products and diligently follow the provided treatment plan.
6. Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds,lacerations, or any other active skin conditions on the face,
7. Subject who agrees not to use any other product/treatment/home remedy/except the provided products on their face during the study period other than the test product,
8. Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period,
9. 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 umbrella to cover face),
10.Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up,
11. Subjects willing to abide by and comply with the study protocol
1. Subject with any other signs of significant local irritation or skin disease,
2. Subjects diagnosed with Mixed and Dermal melasma (wood lamp at inclusion),
3. Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study,
4. Subjects on hormonal therapy (contraceptive, TSH) for at least 6 months,
5. Subjects who are pregnant, breastfeeding or have any plans of pregnancy,
6. Subjects planning a pregnancy 4 months after the end of the study period,
7. Patient applying irritants (2 weeks wash out),
8. Subjects who recently had a skin lightening skin procedure in the past 8 weeks,
9. Subjects using corticosteroids.
10. Subjects who have been taking antiepileptic medications for the previous six months,
11.Subjects with a history of any other dermatosis of the face or known photosensitivity,
12.Subject who is undergoing topical treatment with Sun Protection Factor in past 1 month,
13.Subject having any facial procedure planned during the course of the study,
14.Patient who underwent phototherapy in past 1 month wash out,
15.Subjects with any other active skin condition that may interfere with the study results,
16.Subjects with a known history of allergenic reaction to any components of the products,
17.Subjects who have participated in any other clinical trial in the last 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare Test Product to Cysteamine 5% in terms of <br/ ><br>raw value of mMASI at M4Timepoint: Month 0, Month 1, Month 2, Month 3, Month 4
- Secondary Outcome Measures
Name Time Method To compare TP to CYS at each evaluation time: <br/ ><br>1. mMASI, in terms of raw value (other than M4) and % <br/ ><br>change from Baseline <br/ ><br>2.Investigator Global Assessment (IGA), in terms of proportion of subjects across the IGA scores (0 to 3). <br/ ><br>3.Skin Hydration, in terms of proportion of subjects across <br/ ><br>the scores (1 to 5) <br/ ><br>4.Evenness of Skin tone, in terms of proportion of subjects across the scores. <br/ ><br>5.Subject Self-Assessment Questionnaire (VAS 0 to 5), in <br/ ><br>terms of raw value for each question <br/ ><br>6.Satisfaction questionnaire, in terms of proportion of subjects across the categories for each question. <br/ ><br>Timepoint: Month 0, Month 1, Month 2, Month 3, Month 4