Efficacy and Tolerability of Test Product Versus Cysteamine 5% in Treatment of Facial Epidermal Melasma

NCT06278948 | Recruiting

• 1 other identifier: LRP23023-depigmenting cream
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This interventional, randomized, investigator blinded, controlled study conducted in one centre consists in a 4-month evaluation period within the same season avoiding sunny season on 140 subjects with facial epidermal melasma.

Conditions

Melasma

Keywords

facial epidermal melasma; MASI; Cysteamine 5%

Outcome Measures

Primary Outcomes (2)

• change in mMASI scoring

  the mMASI is calculated using 3 components: four regions of the face (forehead, right malar, left malar and chin); area of involvement for each region (using a scale from 0 to 6): darkness compared to the surrounding normal skin for each area (evaluated using a scale from 0 to 4).

  from baseline to Day112

• change in Investigator's Global Assessment (IGA)

  The investigator evaluates the severity of melasma using a 4-point scale (from 0 (cleared, almost cleared) to 3 (severe (markedly darker than the surrounding normal skin)).

  from baseline to Day112

Secondary Outcomes (1)

• change in Subject Global Assessment of Improvement (SGAI)

  from Day28 to Day112

Study Arms (2)

Group TP: Test Product

EXPERIMENTAL

Subjects (aged 20-50 years) with mild to severe facial epidermal melasma for more than 1 year

Other: Group TP

Group CYS: Cysteamine 5%

ACTIVE COMPARATOR

Subjects (aged 20-50 years) with mild to severe facial epidermal melasma for more than 1 year

Drug: Group CYS

Interventions

Group TP OTHER

Application full face, twice daily, in the morning and at bedtime for 4 months

Also known as: Test Product

Group TP: Test Product

Group CYS DRUG

Application short contact, of thin layer once daily at bedtime for 4 months

Also known as: Cysteamine 5%

Group CYS: Cysteamine 5%

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Facial epidermal melasma (exclude mixed and dermal melasma)
• Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face

You may not qualify if:

• Subjects with any other signs of significant irritation or skin disease
• Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study
• Subjects who had a skin lightening procedure in the past 8 weeks

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (1)

MS Clinical Research Pvt. Ltd

Bangalore, India

RECRUITING

MeSH Terms

Conditions

Melanosis

Interventions

enkephalin, Ala(2)-cysteamine(5)-

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mukta Sachdev

  MS Clinical Research Pvt. Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mukta Sachdev

CONTACT

+91 8041125934; mukta.sachdev@msclinical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: October 6, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

IN (1)