Comparative Study of Test Product and Cysteamine 5% in Treating Facial Epidermal Melasma

Phase 2

Not yet recruiting

• Conditions: Other melanin hyperpigmentation,

• Registration Number: CTRI/2023/10/058259
• Lead Sponsor: La Roche-Posay Laboratoire Dermatologique

Brief Summary

This study is to compare the efficacy and tolerability of a new depigmenting cosmetic formulation versus Cysteamine 5% in the acute management of melasma over 4 months. The study will be conducted for a period of approximately 4 months for each subject and will include a total of 6 visits. A total of 140 subjects will be enrolled and 120 subjects are expected to complete the study. Various assessment Digital Imaging VISIACR®→ Dermatological Examination → Spectrophotometer® reading→ subject self-assessment will be done for the entire study duration for comparing the two groups..

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-09-15
• Study Start: 2024-03-09

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Adult subjects in general good health as determined from a recent medical history, general physical examination, dermatological assessment.
• Subjects of Phototype III, IV, V, 3.
• Subjects diagnosed with facial epidermal Melasma (exclude mixed and dermal melasma) for more than 1 year.
• 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.
• 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.

Exclusion Criteria

• 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.
• 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	Month 0, Month 1, Month 2, Month 3, Month 4
raw value of mMASI at M4	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:	1. mMASI, in terms of raw value (other than M4) and %

Trial Locations

Locations (1)

MS Clinical Research Pvt Ltd; 🇮🇳 Bangalore, KARNATAKA, India

MS Clinical Research Pvt Ltd

🇮🇳Bangalore, KARNATAKA, India

Dr Mukta Sachdev

Principal investigator

08041125934

mukta.sachdev@msclinical.com