Efficacy and Tolerability of Tested Formula After 3 Months of Treatment of Facial Hyperpigmentation of 3 Origins
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
Cosmetique Active International
72 participants
Jun 14, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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
- 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
Exclusion Criteria4
- 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
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Interventions
application twice a day of the tested product (in the morning and evening) and a sunscreen (in the morning and at midday) to the face for 3 months
Locations(1)
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NCT06253468