Efficacy and Tolerability of the Tested Formula After 3 Months of Treatment of Facial Hyperpigmentation of 3 Origins

Launched by COSMETIQUE ACTIVE INTERNATIONAL · Jan 30, 2024

Keywords

ClinConnect Summary

Hyperpigmentation is a common skin condition in which the color of the skin becomes darker. These changes result from an excess of melanin production, distribution, or transport which can be caused by various internal and external factors such as genetic predisposition, hormonal changes, inflammation, acne, ultraviolet (UV) exposure.

Typical hyperpigmentation disorders include post-inflammatory hyperpigmentation, melasma and solar lentigines.

This open, single-centre, three-arm study is carried out with a new cosmetic formulation developed with the aim of acting on facial hyperpigmentatio...

Gender

ALL

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 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

Trial Officials