Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473974
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-19
Brief Title:
Open-label Single-arm Proof of Concept Study in Subjects With Mild-to-moderate Facial Hyperpigmentation
Sponsor:
Kayuraeffect LLP
Organization:
Kayuraeffect LLP
Study Overview
Official Title:
An Open-label Single Arm Proof of Concept Study to Evaluate the Efficacy Tolerability and Safety of Bright Aura Hyperpigmentation Treatment in Subjects With Mild-to-moderate Facial Hyperpigmentation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
K-BRIGHT
Brief Summary:
This research study will test how well hyperpigmentation treatment works for subjects with mild-to-moderate facial hyperpigmentation The study will also test if the hyperpigmentation treatment causes any irritation For 12 weeks of the study participants will use the assigned treatment along with a provided cleanser and sunscreen
Detailed Description:
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 EOTEarly 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
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 EOTEarly 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None