Clinical Study of CS-001 As a Treatment for Canities (Grey Hair)

Phase 3

Not yet recruiting

• Conditions: Canities; Grey Hair
• Interventions: Drug: CS-001; Drug: Placebo Topical Solution

• Registration Number: NCT06745336
• Lead Sponsor: Applied Biology, Inc.

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 Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-24
• Study Start: 2025-06-15
• Primary Completion: 2027-06-15
• Study Completion: 2027-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CS-001	CS-001	CS-001 Topical Treatment
Placebo	Placebo Topical Solution	Placebo Topical Treatment

Primary Outcome Measures

Name	Time	Method
Greying Severity Score	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