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

Applied Biology

Status and phase: Begins enrollment in 4 months; Phase 3

Conditions: Grey Hair; Canities

Treatments: Drug: CS-001; Drug: Placebo Topical Solution

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06745336

CS-001

Details and patient eligibility

About

Clinical Study to Assess the Safety and Efficacy of CS-001 as a treatment for Canities (Grey Hair)

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups, including a placebo group

CS-001

Experimental group

Description:

CS-001 Topical Treatment

Treatment:

Drug: CS-001

Placebo

Placebo Comparator group

Description:

Placebo Topical Treatment

Treatment:

Drug: Placebo Topical Solution