Evaluating a new treatment for facial hyperpigmentation

Evaluation of the Efficacy and Tolerability of the Tested Formula BID After 3 Months in the Treatment of Facial Hyperpigmentation of 3 Origins: Melasma, Acne Induced Post-Inflammatory Hyperpigmentation and Solar Lentigo

This study is testing a new cream to see if it can help people with dark spots on their face, like melasma or acne scars, look better after using it for three months.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cosmetique Active International (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Singapore)
• Trial ID: NCT06253468 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and cosmetic acceptability of a new formulation for treating facial hyperpigmentation, including conditions like melasma and post-inflammatory hyperpigmentation from acne. Conducted over three months, participants will apply the product twice daily and undergo evaluations to measure improvements in their skin condition. The study follows strict ethical guidelines and employs a mixed-effect model for analyzing efficacy data while presenting safety data descriptively.

Who should consider this trial

Good fit: Ideal candidates include adult females with mild to moderate melasma, acne-induced post-inflammatory hyperpigmentation, or solar lentigo.

Not a fit: Patients with severe melasma, other facial pigmentary disorders, or inflammatory skin conditions will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the appearance of facial hyperpigmentation for affected patients.

How similar studies have performed: While there have been studies on hyperpigmentation treatments, this specific formulation and approach may offer novel insights into efficacy and tolerability.

Eligibility criteria

Inclusion Criteria:

* all phototypes
* only one of the following pigmentary conditions on the face: epidermal or mixed, mild to moderate melasma; mild to moderate acne-induced PIHP; solar lentigo
* female patient of childbearing potential must use one of the reliable methods of contraception and agree not to change it during the study
* patient agreeing not to be exposed to ultraviolet radiation (UV), natural (sun) or artificial (tanning salon), during the study

Exclusion Criteria:

* female patient who gave birth less than 3 months prior to Day 0, who is pregnant, breast-feeding or who plans to become pregnant during the study
* male patient with beard or facial hair, which would interfere with clinical evaluation or clinical procedure baseline)
* patient with any inflammatory dermatosis of the face such as seborrheic dermatitis, rosacea etc.
* severe melasma, dermal melasma
* patient with facial pigmentary disorders other than those described in inclusion criteria
* patient who has used topical depigmenting agents such as hydroquinone and derivatives, glycolic acid, kojic acid, retinoids and derivatives, azelaic acid, niacinamide within 1 month prior to Day 0/Baseline visit
* patient who has used systemic treatments such as tranexamic acid and oral melatonin within 1 month prior to Day 0/Baseline visit;
* patient who has used drugs inducing pigmentation such as tetracyclines, fluoroquinolones, antiepileptics within 1 month prior to Day 0/Baseline visit

Where this trial is running

Singapore

• National Skin Care Centre — Singapore, Singapore (RECRUITING)

Study contacts

• Principal investigator: Steven Thng — National Skin Care Centre
• Study coordinator: Steven Thng

Conditions: Hyperpigmentation, facial hyperpigmentation, melasma, acne induced PIHP, solar lentigo