Evaluating a new formula for treating facial hyperpigmentation
Evaluation of the Efficacy and Tolerability of the Tested Formula 2039125 03 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 facial dark spots like melasma and acne marks look better after using it for three months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cosmetique Active International Industry-sponsored |
| Locations | 1 site (Lisboa) |
| Trial ID | NCT06320314 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy and cosmetic acceptability of a new cosmetic formulation (2039125 03) for treating facial hyperpigmentation, specifically targeting mild to moderate melasma, acne-induced post-inflammatory hyperpigmentation, and solar lentigo. Conducted as an open, single-centre, three-arm study, participants will apply the product twice daily for three months. The study will analyze the improvement in skin pigmentation using a mixed-effect model for quantitative parameters, while safety data will be presented 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: Other studies have shown promise in treating facial hyperpigmentation with similar cosmetic formulations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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. 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
Where this trial is running
Lisboa
- PhDTrials Center — Lisboa, Portugal (Recruiting)
Study contacts
- Principal investigator: Pedro Pinto — PhDTrials center
- Study coordinator: Pedro Pinto
- Email: geral@phdtrials.com
- Phone: +351 216034267
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.