Open-label, Single-arm, Proof of Concept Study in Subjects with Mild-to-moderate Facial Hyperpigmentation

Hyperpigmentation of the skin is a common dermatological condition in which the colour of the skin generally becomes darker. These changes in skin coloration can be a result of various internal and external factors including hormonal changes, inflammation, injury, acne, eczema, certain medication, ultraviolet (UV) exposure, etc. Skin pigmentation and colouration are governed by the biological processes involving the production of the skin pigment called melanin produced by melanocytes in various layers of skin. Various commonly observed hyperpigmentation disorders include melasma, post inflammatory hyperpigmentation, ephelides, lentigines and Hyperpigmentation of the skin is a common dermatological condition in which the colour of the skin generally becomes darker. These changes in skin coloration can be a result of various internal and external factors including hormonal changes, inflammation, injury, acne, eczema, certain medication, ultraviolet (UV) exposure, etc. Skin pigmentation and colouration are governed by the biological processes involving the production of the skin pigment called melanin produced by melanocytes in various layers of skin. Various commonly observed hyperpigmentation disorders include melasma, post inflammatory hyperpigmentation, ephelides, lentigines and many more. The histopathology of hyperpigmentation can vary with the various pigmentation disorders. Increased melanin content in both the epidermis and dermis and mild perivascular lymph histiocytic infiltrate. Immunohistochemistry analysis suggests enlarged melanocytes with prominent dendrites, a larger number of dermal melanophages and their melanin deposition. The potential targets for the depigmenting and hyperpigmentation control agents include various cell receptor antagonists, inhibitors of melanocyte stimulation, tyrosinase enzyme inhibitors, inhibitors of melanosome transfer, and degraders of formed melanin in keratinocytes. Non-ablative skin resurfacing procedures are also effective for improving the appearance of photodamaged and hyperpigmented skin and are becoming increasingly popular because of their minimal downtime and increased safety. These procedures include intense pulsed light systems, non-ablative lasers, and chemical peelings, which can target facial rhytids, irregular pigmentation, melanin elimination, and dermal reorganization. Unfortunately, such techniques can be expensive and their use is primarily limited to clinical settings. However, the Bright Aura Hyperpigmentation Treatment is a light source that is well-suited for all the skin types that can be utilized at home for a relatively low price. This is an open-label, single arm, proof of concept study to evaluate efficacy, tolerability and safety of test cosmetic product (Bright Aura Hyperpigmentation Treatment) for topical use in 24 subjects with mild-to-moderate facial hyperpigmentation (including but not limited to melasma, PIH, solar lentigines, or dark spots, etc.) and Fitzpatrick skin type I-VI. The study duration will be 13 weeks (1 week of screening and 12 weeks of treatment period) as mentioned below: Screening period: Visit 1 \[Day -7 to -1 (Week -1 to 0)\] Baseline \& enrolment: Visit 2 \[Day 0 (Week 0)\] Treatment period: Visit 3 \[Day 15 +2 (week 2)\] Visit 4 \[Day 29 ±3 (Week 4)\] Visit 5 \[Day 57 ±3 (Week 8)\] End of treatment (EOT)/Early discontinuation: Visit 6 \[Day 85 ±3 (Week 12)\] This study will evaluate the efficacy, tolerability (safety in use), and safety of Bright Aura Hyperpigmentation Treatment in subjects with mild-to-moderate facial hyperpigmentation.