Efficacy and Tolerability of the Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins
Recruiting
N/AInterventional Study
Hyperpigmentation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
60 (estimated)
Sponsor
Cosmetique Active International · Industry
Who this trial is looking for
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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.
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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 ag…
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
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