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Cosmetic Product for Facial Hyperpigmentation (K-BRIGHT Trial)

Phase 2
Waitlist Available
Research Sponsored by Kayuraeffect, LLP
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
For female subjects: Females of non-childbearing potential who are surgically sterile at least 6 months prior to first IP application or congenitally sterile as assessed by a physician, or 1-year postmenopausal in women not using hormonal contraception or hormonal replacement therapy. Females of childbearing potential must have negative serum and urine pregnancy tests at screening visit and baseline, and willing to use highly effective methods of contraception throughout the study and for 7 days after last application
Must not have
Subjects with a history of skin cancer
Subjects with an uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or hypothyroidism
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 2, 4, 8 and 12
Awards & highlights
No Placebo-Only Group

Summary

"This trial will investigate the effectiveness of a hyperpigmentation treatment for people with mild-to-moderate facial hyperpigmentation. Participants will use the treatment and other products provided for 12 weeks to see

Who is the study for?
This trial is for individuals with mild-to-moderate facial hyperpigmentation. Participants will use a test cosmetic product along with provided cleanser and sunscreen for 12 weeks.
What is being tested?
The study tests the effectiveness of a new treatment for reducing facial hyperpigmentation and its potential to cause skin irritation.
What are the potential side effects?
Potential side effects may include skin irritation or allergic reactions related to the test cosmetic product.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I will not undergo any facial treatments like Botox, fillers, or laser during the study.
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I am a woman not able to have children, had surgery to ensure this, or am postmenopausal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had skin cancer in the past.
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I do not have uncontrolled asthma, diabetes, high blood pressure, or thyroid issues.
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I am not pregnant, nursing, or planning to become pregnant during the study.
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I am willing and able to follow all study visits, treatments, and test schedules.
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I have recently had facial cosmetic procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 2, 4, 8 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 2, 4, 8 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall hyperpigmentation score using modified Griffiths 10-point scale.
Secondary study objectives
Change from baseline in melasma quality of life (MELASQOL) scale total score.
Change from baseline in melasma severity rating scale score.
Change from baseline in modified melasma area severity index (MASI) score.
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participation Group/Arm.Experimental Treatment1 Intervention
Experimental: Test cosmetic product Other: Cleanser and sunscreen

Find a Location

Who is running the clinical trial?

Kayuraeffect, LLPLead Sponsor
COD ResearchUNKNOWN
Dr. Prayag Shah, MD, MBAStudy DirectorIntra-group cooperation or coordination
~12 spots leftby Jan 2025
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