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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06745336

Enrollment

240

Registered

2024-12-20

Start date

2025-06-15

Completion date

2027-09-15

Last updated

2024-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Canities, Grey Hair

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.

Interventions

DRUGCS-001

CS-001 Topical Treatment

DRUGPlacebo Topical Solution

Placebo Topical Solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Contacts

Primary ContactAndy Goren, MD

clincalstudies@appliedbiology.com6507040850

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026