Open-label, Single-arm, Proof of Concept Study in Subjects With Mild-to-moderate Facial Hyperpigmentation
NCT Number: NCT06473974
Acronym: K-BRIGHT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Facial Hyperpigmentation
Interventions: DRUG: Test cosmetic product
Sponsor: Kayuraeffect, LLP
Collaborators: COD Research
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-03-15
Locations: Delux Health Centre, LLC,, Miami Lakes, Florida, 33014, United States|Pioneer Clinical research, New York, New York, 10016, United States

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.

Primary Outcome Measures: 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., Baseline to week 12.
Secondary Outcome Measures: 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., 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)., 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)., 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., 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., 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., 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, 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., 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., 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, 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., at week 2, 4, 8 and 12