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

This clinical trial is looking at a new product designed to help reduce facial hyperpigmentation, which can happen for various reasons, like melasma (dark patches on the skin), post-inflammatory hyperpigmentation from acne, or age spots from sun exposure. Over a period of three months, participants will use this product twice a day to see how effective it is at lightening these dark spots and improving their overall skin appearance. The study also aims to understand how well people accept using this product in their daily routines.

To participate, you need to be an adult aged 18 or older with one of the specific types of facial hyperpigmentation mentioned earlier. It’s important that you’re not pregnant or breastfeeding and that you haven’t used certain skin lightening treatments or medications in the month before the study starts. Participants will be asked to avoid sun exposure during the trial to ensure the best results. Overall, this study aims to find a safe and effective way to help those struggling with these skin conditions feel more confident about their appearance.

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