Facial HyperpigmentationPhase 2K-BRIGHTNCT06473974
Open-label, Single-arm, Proof of Concept Study in Subjects with Mild-to-moderate Facial Hyperpigmentation
A Phase 2 study testing Test cosmetic product in people with Facial Hyperpigmentation, run by Kayuraeffect, LLP at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Facial Hyperpigmentation
- What is being tested?
- Test cosmetic product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2025to 15 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Willing and able to provide written informed consent for the study before the initiation of any study-specific procedures.
- Female or male aged 18-60 years (both inclusive), with Fitzpatrick skin types I-VI.
- Subjects with mild-to-moderate facial hyperpigmentation (including but not limited to melasma, PIH, solar lentigines, or dark spots, etc.) based on modified Griffiths 10-point scale.
- Note:
- Affected areas include the forehead, cheeks (malar), nose, perioral area, and chin.
- Men who shaved regularly (at least three times weekly) with no beards will be allowed to participate.
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- Subjects of all races and ethnicities including, but not limited to, Caucasian, African-American, Latino, Asian, Middle Eastern and East Indian will be enrolled for the present study.
- Subjects willing to sign have their photographs taken during the study and willing to sign a photography release.
- Willing to withhold all facial treatments during the course of the study including botulinum toxin, injectable fillers, microdermabrasion, Intense pulsed light (IPL), peels, facials, waxing, laser treatments and tightening treatments. Threading is allowed but not facial laser hair removal.
- Willing to cooperate and participate by following study requirements for the duration of the study and to report any changes in health status or medications, adverse event symptoms, or reactions immediately.
- Subjects willing to use cosmetic product regimen on their face provided by the sponsor (e.g. Cleanser, and Sunscreen).
- Willingness to not begin using any new cosmetic facial make-up during the study. If regular users of cosmetic facial make-up, they must have used the products without any tolerability issues for at least 2 weeks prior to starting the study.
- Willingness to avoid facial makeup tattoos including but not limited to eyebrows, eye line, lips or lash extensions during the 12-week study.
- Willingness to avoid as much as possible, direct and prolonged sun exposure for the duration of the study (including tanning beds), especially from 10 AM to 2 PM. Subjects will be instructed to wear protective clothing prior to and during exposure. Any extended sun exposure must be recorded in the source documents.
- Male subjects (including vasectomized) with partners who are of childbearing potential (whether pregnant or not) must use condoms prior to first IP application and until 7 days after last IP application. Male subjects should also avoid semen donation or providing semen for in-vitro fertilization during the above mentioned duration.
- For female subjects:
- Females of non-childbearing potential who are surgically sterile (documented hysterectomy, bilateral oophorectomy or bilateral salpingectomy) at least 6 months prior to first IP application or congenitally sterile as assessed by a physician, or 1-year postmenopausal (no menses for 12 months without an alternative medical cause plus serum follicle stimulating hormone [FSH] levels consistent with postmenopausal status) in women not using hormonal contraception or hormonal replacement therapy.
- Females of childbearing potential must:
- Have negative serum pregnancy test at screening visit; ii. Have negative urine pregnancy test at baseline prior to initiating the treatment.
- Willing to use highly effective methods of contraception throughout the study and for 7 days after last application.
Who cannot join
- Unwilling or unable to comply with scheduled visits, cosmetic product application plan, laboratory tests, or other study procedures and study restrictions.
- Subjects diagnosed with known allergies to study provided skin care products.
- Subjects who are nursing, pregnant, or planning to become pregnant during the study according to subject self-report.
- Subjects with a history of skin cancer.
- Subjects having a health condition and/or pre-existing or dormant dermatologic disease on the face/planned treatment area (e.g. psoriasis, rosacea, acne, eczema, seborrheic dermatitis, severe excoriation) that the investigator or designee deems inappropriate for participation or could interfere with the outcome of the study.
- Subjects with facial plastic surgery or ablative laser resurfacing during the past year; non-ablative laser resurfacing, neurotoxins, or dermal fillers during the previous 3 months; superficial resurfacing treatment (chemical peels, microdermabrasion, micro-needling), neurotoxin or dermal fillers during the previous 6 weeks.
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- Subjects with a history of immunosuppression/immune deficiency disorders [including (HIV infection or AIDS) or currently using immunosuppressive medications (e.g. azathioprine, belimumab, cyclophosphamide, etanercept, adalimumab, mycophenolate mofetil, methotrexate, prednisone, infliximab, ustekinumab) and/or radiation as determined by study documentation that the investigator or designee deems inappropriate for participation or could interfere with the outcome of the study.
- Subjects with an uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or hypothyroidism. Subjects having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medications, etc.
- Subjects who are currently participating in any other facial usage study or have participated in any clinical trial within 4 weeks prior to inclusion into the study.
- Subjects who have observable suntan, scars, nevi, excessive hair, etc., or other dermal conditions on the face that might influence the test results in the opinion of the investigator or designee.
- Subjects who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.
- Individuals who used any of the following medications or had any of the listed procedures within the listed time frame prior to the study start date:
- Tretinoin, Tazarotene, or Adapalene within 3 months. ii. Had a light-depth chemical peel, medium-depth microdermabrasion, any systemic steroids, non-ablative laser, light and/or ratio frequency or fractional laser resurfacing of the face and neck within 01 month.
- Any systemic retinoid (e.g. Acitretin, Isotretinoin) within 5 half-lives of its last dose.
- Oral Tranexamic acid or topical applications containing depigmenting agents within 5 half-lives of its last dose.
- Any topical or systemic antibiotics, such as minocycline, or any other known medications that can cause photosynthesis, such as hydrochlorothiazide, furosemide, amiodarone, within 5 half-lives of its last dose.
- Any topical tretinoin product or derivative, imiquimod, 5-fluororuacil, or diclofenac on their face within 01 month.
- Prescription strength skin lightening products (e.g. hydroquinone, tretinoin, α-hydroxy acid, β-hydroxy acid, and polyhydroxy acids, azelaic acid, 4-hydroxyanisole alone or in combination with tretinoin, etc.) within 01 month.
- Any non-prescription cosmetic anti-wrinkle, skin lightening products, or any other product or topical or systemic medication known to affect skin aging or dyschromia (products containing alpha/beta/poly-hydroxy acids, vitamin C, soy, Q-10, hydroquinone; systemic or liquorice extract (topically), Tego® Cosmo C250, gigawhite, lemon juice extract (topically), emblica extract, etc.) within 2 weeks.
- Have undergone plastic surgery, Dermabrasion (deep skin peel), a deep chemical peel or ablative laser resurfacing of the face and neck within 12 months.
- Had facial treatment with a botulinum toxin base injectable (Botox), injectable fillers, or a fat transfer within 6 months.
- At the time of signing the informed consent document (ICD), if the subject is a regular user (including "recreational use") of any illicit drug or has a recent history (within the past year) of substance abuse (including alcohol).
- Immediate family member who is at the research site or sponsoring staff who is directly involved in this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Delux Health Centre, LLC,
Miami Lakes, Florida, 33014
Pioneer Clinical research
New York, New York, 10016
About this study
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
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.
Read the 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 (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.
- Conditions
- Facial Hyperpigmentation
- Being tested
- Test cosmetic product
- Keywords
- Hyperpigmentation, skin disease, melasma, wrinkles
- Medical subject headings
- Hyperpigmentation, Skin Diseases, Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test cosmetic productDrug
Also called Cleanser and Sunscreen
Test cosmetic product: Test cosmetic product will be applied to affected hyperpigmented areas twice daily at AM and PM.
Cleanser and sunscreen: A facial cleanser will be used twice daily (morning and evening) by gently rubbing it on face and neck, then rinse and pat dry. Sunscreen of SPF 50, apply evenly on face and neck, 20 minutes before stepping out.
| Study group | Role | What they receive |
|---|---|---|
| Participation Group/Arm. | Other | Experimental: Test cosmetic product Other: Cleanser and sunscreen Receives: Drug: Test cosmetic product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall hyperpigmentation score using modified Griffiths 10-point scale.
Investigator will evaluate the face of each subject for overall hyperpigmentation using a modified Griffith's 10-point scale at all visits. The score range from 0 to 9 where, 0=none; 1-3=mild; 4-6=moderate; and 7-9=severe. Change from baseline will be calculated, a negative change from baseline show improvement.
Measured: Baseline to week 12.
Secondary outcomes (11)
Overall hyperpigmentation score using modified Griffith's 10-point scale.
Investigator will evaluate the face of each subject for overall hyperpigmentation using a modified Griffith's 10-point scale at all visits. The score range from 0 to 9 where, 0=none; 1-3=mild; 4-6=moderate; and 7-9=severe. Change from baseline will be calculated, a negative change from baseline show improvement.
Measured: Baseline to week 2, 4 & 8
Number of participant by response for self-assessment questionnaire: Overall improvement in skin condition.
Using the Subject Self-Assessment Questionnaire, Overall Improvement, the participant will select a response that best represented their feelings on the overall improvement in their skin condition compared to the beginning of the study. Responses were categorized as: 0=No change or a worsening in my skin condition (dark areas of color on skin), 1=I see a slight improvement in my skin condition (approximately 25% overall improvement), 2=I see a moderate improvement in my skin condition (approximately 50% overall improvement), 3=I see a marked improvement in my skin condition (approximately 75% overall improvement), 4=I see a complete clearing of my skin condition (approximately 95% or better overall improvement).
Measured: At week 2, 4, 8 and 12
Number of participant by response for self-assessment questionnaire: Overall satisfaction with test product.
Using the Subject Self-Assessment Questionnaire: Satisfaction with Treatment, the participant will select a response that best represented their overall satisfaction with the test product. Responses were categorized as: 1=Excellent (very satisfied), 2=Good (moderately satisfied), 3=Fair (slightly satisfied) and 4=Poor (not satisfied at all).
Measured: At week 2, 4, 8 and 12
Investigator global assessment for overall hyperpigmentation.
Investigator will assess the subject's face for improvement in overall hyperpigmentation. The score ranged from 0 to 4 where, 0=No change or worsening, 1=Mild improvement (approximately 25% overall improvement), 2=Moderate improvement (approximately 50% overall improvement), 3=Marked improvement (approximately 75% overall improvement), 4=Complete clearing/Dramatic improvement (approximately 95% plus overall improvement). The mean score for overall hyperpigmentation will be reported.
Measured: Baseline to week 2, 4, 8 and 12
Investigator global assessment for photodamage scores.
Investigator will evaluate the face of each subject for global improvement for photodamage. The score ranged from 0 to 9 where, 0=none, facial skin is smooth to the touch; 1-3=Mild, Facial skin shows 1 area of significant roughness, skin tone unevenness (red/brown), or fine/coarse lines; 4-6=Moderate, Facial skin shows 2 areas of significant roughness, skin tone unevenness (red/brown), or fine/coarse lines, 7-9=Severe, Facial skin shows 3 or more areas of significant roughness, skin tone unevenness (red/brown), or fine/coarse lines. The mean score for photodamage will be reported.
Measured: Baseline to week 2, 4, 8 and 12
Investigator global assessment for fine lines/wrinkles, coarse lines/wrinkles, overall skin-tone evenness and tactile roughness
Investigator will evaluate as per score ranged from 0 to 9:
Fine lines/wrinkles: 0=No fine lines/wrinkles; 1-3=Rare fine lines and wrinkles, 4-6=Moderate fine lines and wrinkles, 7-9= Many fine lines/wrinkles.Coarse lines/wrinkles: 0=No coarse lines/wrinkles, 1-3=Mild, Rare coarse lines and wrinkles, 4-6=Moderate coarse lines/wrinkles iin the treatment area; 7-9=Many coarse lines/wrinkles in the treatment area. Skin tone/evenness: 0= No skin tone unevenness, 1-3=Mild skin tone unevenness, 4-6=Moderate skin tone unevenness; 7-9=Severe skin tone unevenness.Tactile roughness: 0=No roughness of the treatment area,1-3=slightly irregular roughness in the treatment area; 4-6=definite roughness of the treatment area; 7-9= Marked roughness of the treatment area associated with stiff feeling.
Measured: Baseline to week 2, 4, 8 and 12
Change from baseline in melasma severity rating scale score.
Investigator will evaluate the face of each subject for global improvement for subject appearance. The score ranged from 0 to 9 where, 0=Cleared: color of melasma lesions approximately equivalent to surrounding normal skin or with minimal residual hyperpigmentation, 1=Mild: color slightly darker than the surrounding normal skin, 2= Moderate: color moderately darker than the surrounding normal skin, 3= Severe: color markedly darker than the surrounding normal skin
Measured: Baseline to week 2, 4, 8 and 12
Change from baseline in modified melasma area severity index (MASI) score.
The investigator assigned a grade face for each of the following: A=Total Area Involved (0=No involvement to 6=90 to 100% involvement); and D=Darkness of Pigment (0=Normal skin color to 4=Severe hyperpigmentation) for forehead [F], right malar [RM], left malar [LM], and chin [C]. Total Face MASI score will be calculated as: 0.3 x DF x AF + 0.3 x DRM x ARM + 0.3 x DLM x ALM + 0.1 x Dc x Ac. A negative change from Baseline indicates improvement.
Measured: Baseline to week 2, 4, 8 and 12
Change from baseline in melasma quality of life (MELASQOL) scale total score.
The Melasma Quality of Life Scale assesses the effect melasma has on the quality of life of sufferers on a scale of 1 (not bothered at all) to 7 (bothered all of the time), rating the following questions: 1.The appearance of your skin condition 2.Frustration about your skin condition. 3. Embarrassment about your skin condition. 4. Feeling depressed about your skin condition. 5. The effects of your skin condition on your interactions with other people. 6. The effects of your skin condition on your desire to be with people. 7. Your skin condition making it hard to show affection. 8. Skin discoloration making you feel unattractive to others. 9. Skin discoloration making you feel less vital or productive. 10. Skin discoloration affecting your sense of freedom. The MELASQOL is scored from 7 to 70, with a higher score indicating worse melasma-related health-related quality of life. A negative change from Baseline indicates improvement.
Measured: baseline to week 2 and 12
Investigator assessment for objective evidence of erythema, edema, dryness, and scaling on 4-point scale.
Investigatorwillassessthesubjectsonobjective evidence of erythema, edema, dryness and scaling on a 4-point scale.sErythema: 0=No erythema of the treatment area; 1=Mild: Slight, but definite redness of the treatment area; 2=Moderate: Definite redness of the treatment area; 3=Severe: Marked redness of the treatment area. Edema:0=No edema/swelling of the treatment area; 1=Mild: Slight, but definite edemaofthe treatment area; 2=Moderate: Definite edema of the treatment area; 3=Severe: Marked edema of the treatment area. Dryness:0=No dryness of the treatment area;1=Mild, Slight, but definite dryness of the treatment area; 2=Moderate, Definite dryness of the treatment area; 3=Severe, Marked dryness ofthe treatment area. Scaling: 0=Noscaling of the treatment area; 1=Mild, Barely perceptible, fine scales in limited areas of the treatment area; 2=Moderate, Finescaling generalized to all areas of the treatment area; 3=Severe scalingandpeeling ofskin over all areas of the treatment area
Measured: at week 2, 4, 8 and 12
Subjective assessment for irritation parameters including burning, stinging and itching on 4-point scale.
Subjectwillassessthemselvesforirritationparametersincludingburning,stinginganditchingona4pointscaleBurning:0=Noburning;1=MildSlightburningsensation;2=ModerateDefinitewarm,burningofthetreatmentarea that is somewhat bothersome;3=Severe:Hot burningsensationof the treatmentarea thatcausesdefinitediscomfortandmayinterruptdailyactivitiesand/orsleep.Stinging:0=Nostinging of the treatment area;1=Mild:Slightstingingsensationof the treatment area;not reallybothersome;2=Moderate:Definitestingingofthetreatmentareathatissomewhatbothersome;3=Severe: Marked stinging sensationof thetreatment;area thatcauses definitediscomfortandmayinterruptdailyactivitiesand/orsleep.Itching: 0=Noitchingofthetreatment area;1=MildSlightitchingsensationofthetreatment area;notreallybothersome;2=Moderate: Definiteitchingofthetreatmentareathatissomewhatbothersome;3=Severe:Markeditchingsensationofthetreatmentareathatcausesdefinitediscomfortandmay interruptdailyactivitiesand/orsleep.
Measured: at week 2, 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Jan 2025 (estimated)
- Primary completion10 May 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Why it stopped: This study had been withdrawn by the sponsor as they are in process to approach FDA with rationale to get agency feedback and share written response on IRB query. Thereafter, they may again approach with new application and FDA written response.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial HyperpigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, Safety and Efficacy
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayuraeffect, LLP
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- COD Research
- Responsible party
- Sponsor
- Investigators
- Dr. Prayag Shah, MD, MBA, Study director, Intra-group cooperation or coordination
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473974
- Sponsor's protocol ID
- COD-24-011
- Acronym
- K-BRIGHT
- Status last verified
- Aug 2024
- First submitted
- 19 Jun 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06473974
- Acronym / sponsor ID
- K-BRIGHT / COD-24-011
- Conditions
- Facial Hyperpigmentation
- Keywords
- Hyperpigmentation, skin disease, melasma, wrinkles
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study had been withdrawn by the sponsor as they are in process to approach FDA with rationale to get agency feedback and share written response on IRB query. Thereafter, they may again approach with new application and FDA written response.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kayuraeffect, LLPIndustry (pharma, biotech, devices)
- Collaborators
- COD Research
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 10 May 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, Safety and Efficacy
| Arm | Type | Receives |
|---|---|---|
| Participation Group/Arm. | Other | Drug: Test cosmetic productExperimental: Test cosmetic product Other: Cleanser and sunscreen |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Willing and able to provide written informed consent for the study before the initiation of any study-specific procedures.
- Female or male aged 18-60 years (both inclusive), with Fitzpatrick skin types I-VI.
- Subjects with mild-to-moderate facial hyperpigmentation (including but not limited to melasma, PIH, solar lentigines, or dark spots, etc.) based on modified Griffiths 10-point scale.
- Subjects willing to sign have their photographs taken during the study and willing to sign a photography release.
- Willing to withhold all facial treatments during the course of the study including botulinum toxin, injectable fillers, microdermabrasion, Intense pulsed light (IPL), peels, facials, waxing, laser treatments and tightening treatments. Threading is allowed but not facial laser hair removal.
Key exclusion criteria (23 listed)
- Unwilling or unable to comply with scheduled visits, cosmetic product application plan, laboratory tests, or other study procedures and study restrictions.
- Subjects diagnosed with known allergies to study provided skin care products.
- Subjects who are nursing, pregnant, or planning to become pregnant during the study according to subject self-report.
- Subjects with a history of skin cancer.
- Subjects having a health condition and/or pre-existing or dormant dermatologic disease on the face/planned treatment area (e.g. psoriasis, rosacea, acne, eczema, seborrheic dermatitis, severe excoriation) that the investigator or designee deems inappropriate for participation or could interfere with the outcome of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test cosmetic productAlso: Cleanser and SunscreenTest cosmetic product: Test cosmetic product will be applied to affected hyperpigmented areas twice daily at AM and PM. Cleanser and sunscreen: A facial cleanser will be used twice daily (morning and evening) by gently rubbing it on face and neck, then rinse and pat dry. Sunscreen of SPF 50, apply evenly on face and neck, 20 minutes before stepping out. | Drug | Participation Group/Arm. |
Primary outcome
Overall hyperpigmentation score using modified Griffiths 10-point scale.
Time frame: Baseline to week 12.
Investigator will evaluate the face of each subject for overall hyperpigmentation using a modified Griffith's 10-point scale at all visits. The score range from 0 to 9 where, 0=none; 1-3=mild; 4-6=moderate; and 7-9=severe. Change from baseline will be calculated, a negative change from baseline show improvement.
11 secondary outcomes
Overall hyperpigmentation score using modified Griffith's 10-point scale.
Time frame: Baseline to week 2, 4 & 8
Number of participant by response for self-assessment questionnaire: Overall improvement in skin condition.
Time frame: At week 2, 4, 8 and 12
Number of participant by response for self-assessment questionnaire: Overall satisfaction with test product.
Time frame: At week 2, 4, 8 and 12
Investigator global assessment for overall hyperpigmentation.
Time frame: Baseline to week 2, 4, 8 and 12
Investigator global assessment for photodamage scores.
Time frame: Baseline to week 2, 4, 8 and 12
Investigator global assessment for fine lines/wrinkles, coarse lines/wrinkles, overall skin-tone evenness and tactile roughness
Time frame: Baseline to week 2, 4, 8 and 12
Change from baseline in melasma severity rating scale score.
Time frame: Baseline to week 2, 4, 8 and 12
Change from baseline in modified melasma area severity index (MASI) score.
Time frame: Baseline to week 2, 4, 8 and 12
Change from baseline in melasma quality of life (MELASQOL) scale total score.
Time frame: baseline to week 2 and 12
Investigator assessment for objective evidence of erythema, edema, dryness, and scaling on 4-point scale.
Time frame: at week 2, 4, 8 and 12
Subjective assessment for irritation parameters including burning, stinging and itching on 4-point scale.
Time frame: at week 2, 4, 8 and 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Prayag Shah, MD, MBA study director
Intra-group cooperation or coordination
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Test cosmetic product in people with Facial Hyperpigmentation, run by Kayuraeffect, LLP at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall hyperpigmentation score using modified Griffiths 10-point scale. (time frame: Baseline to week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.