Efficacy and Tolerability of Tested Formula After 3 Months of Treatment of Facial Hyperpigmentation of 3 Origins
Recruiting now · Not applicable
Conditions studied: Hyperpigmentation
In brief
The objective of this study is to evaluate the efficacy, cosmetic acceptability and improvement of the stigmatization of the tested product (2039125 03) used bis in die (BID) for 3 months in adult patients suffering from mild to moderate melasma, or mild to moderate acne induced post-inflammatory hyperpigmentation, or solar lentigo.
Key facts
- Study ID
- NCT06253468
- Run by
- Cosmetique Active International
- People needed
- 72
- Starts
- 2024-06-14
- Expected to finish
- 2025-03-01
- Last updated by the study team
- 2024-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- National Skin Care Centre — Singapore, Singapore (enrolling)
Full record on ClinicalTrials.gov
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