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

Melasma Clinical Trial

Official title:

Randomized Controlled Investigator Blinded Comparative Study of the Efficacy and Tolerability of Test Product Versus Cysteamine 5% in the Treatment of Facial Epidermal Melasma Over 4 Months

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06278948
• Other study ID #: LRP23023-depigmenting cream
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2023
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Cosmetique Active International
• Contact: Mukta Sachdev
• Phone: +91 8041125934
• Email: mukta.sachdev[@]msclinical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Melasma is a very common pigmentation disorder which significantly alters quality of life as per its high visibility on the face. The objective is to compare the efficacy and tolerability of the new depigmenting formulation that addresses the different targets of hyperpigmentation and includes an inhibitor of melanin production with a breakthrough innovative mechanism of action versus Cysteamine 5% in the acute management of melasma over 4 months. Statistics: Sample size calculation: 120 patients (60 per group) are necessary to reach the non-inferiority objective of the Test Product versus Cysteamine 5% on the modified Melasma Area and Severity Index (mMASI) change from Baseline at Month 4. To allow a rate of subjects excluded from analysis (drop out, lost to follow-up, major deviation) at Month 4, 140 subjects in total (70 per group) are enrolled. Statistical analysis: Continuous data collected at each visit will be summarized using common statistical measures such as the count of values, mean, standard deviation, median minimum and maximum. For categorical data, summaries will be provided in terms of frequency counts (n) and percentages (%).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Other:
• Group TP
Application full face, twice daily, in the morning and at bedtime for 4 months

Drug:
• Group CYS
Application short contact, of thin layer once daily at bedtime for 4 months

Locations

Country	Name	City	State
India	MS Clinical Research Pvt. Ltd	Bangalore

Sponsors (1)

Lead Sponsor	Collaborator
Cosmetique Active International

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	change in Subject Global Assessment of Improvement (SGAI)	The subject evaluates the change on a 6-point scale from -1 (worsened) to 4 (totally cleared).	from Day28 to Day112