NCT06745336Not yet recruitingPhase 3
Clinical Study of CS-001 As a Treatment for Canities (Grey Hair)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Applied Biology, Inc.
- Enrollment
- 240
- Primary Endpoint
- Greying Severity Score
Study Overview
Brief Summary
Clinical Study to Assess the Safety and Efficacy of CS-001 as a treatment for Canities (Grey Hair)
Detailed Description
CS-001 is a small molecule that affects lysosomal storage and transfer of melanin from hair follicle melanocytes. In vitro and a small pilot study demonstrated re-pigmentation of grey hair following CS-001 application. The aim of this study is to assess the safety and efficacy of CS-001 as a treatment for grey hair.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 30 to 65
- •Diagnosed with Grey Hair (Canities)
- •Willing and able to apply the treatment as directed, comply with study
- •Otherwise healthy
- •Able to give informed consent
Exclusion Criteria
- •A medical history that may interfere with study objectives
- •Women who are pregnant, lactating, or planning to become pregnant during the study period
- •Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc)
- •Subjects who have known allergies to any excipient in CS-001
- •Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device in the treatment area within 30 days prior to study treatment initiation
- •Subjects who have used any topical prescription medications in the treatment area within 30 days prior to study treatment initiation
- •Subjects who have had a dermatological procedure such as surgery in the treatment area within 30 days prior to study treatment initiation
- •Subject is unable to provide consent or make the allotted clinical visits
Arms & Interventions
CS-001
Experimental
CS-001 Topical Treatment
Intervention: CS-001 (Drug)
Placebo
Placebo Comparator
Placebo Topical Treatment
Intervention: Placebo Topical Solution (Drug)
Outcomes
Primary Outcomes
Greying Severity Score
Time Frame: Week [0,52]
Greying Severity Score (GSS). Mild Greying score between 0-5, Moderate Greying score between 6-10 and Severe Greying score between 11-15
Secondary Outcomes
No secondary outcomes reported
Investigators
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