Treatment for facial hyperpigmentation using a new serum formula
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 serum to see if it can effectively lighten dark spots on the face caused by conditions like melasma and acne marks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cosmetique Active International Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Osasco) |
| Trial ID | NCT06268496 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and cosmetic acceptability of a new serum formula (2039125 03) in treating facial hyperpigmentation conditions such as melasma, acne-induced post-inflammatory hyperpigmentation, and solar lentigo. Conducted as an open, single-centre, three-arm study, participants will apply the serum twice daily for three months, with assessments made through before-and-after comparisons. The study adheres to ethical guidelines and regulatory requirements to ensure participant safety and data integrity.
Who should consider this trial
Good fit: Ideal candidates are adult females with mild to moderate melasma, acne-induced post-inflammatory hyperpigmentation, or solar lentigo who are not pregnant or breastfeeding.
Not a fit: Patients with severe melasma, other facial pigmentary disorders, or inflammatory dermatosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the appearance of facial hyperpigmentation, enhancing patients' quality of life.
How similar studies have performed: While there have been studies on treatments for hyperpigmentation, this specific formulation and approach may offer novel insights into cosmetic treatment efficacy.
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 * 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
Osasco
- Medcin Instituto da Pele Ltda — Osasco, Brazil (Recruiting)
Study contacts
- Principal investigator: Sergio Schalka — Medcin Instituto da Pele Ltda
- Study coordinator: Sergio Schalka
- Email: sergio.schalka@medcin.com.br
- Phone: +55 (11) 3683-5366
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.