Clinical Study of mTOR Inhibitor as a Treatment for Grey Hair (Canities)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2027-09-15

Brief Summary

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Clinical Study to Assess the Safety and Efficacy of CS-002 (mTOR inhibitor) as a treatment for Canities (Grey Hair)

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Detailed Description

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CS-002 is a small molecule that is an mTOR ("mammalian target of rapamycin ") inhibitor. In vitro and a small pilot study demonstrated re-pigmentation of grey hair following CS-002 application. The aim of this study is to assess the safety and efficacy of CS-002 as a treatment for grey hair.

Conditions

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Canities Grey Hair

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CS-002

CS-002 Topical Treatment

Group Type EXPERIMENTAL

CS-002

Intervention Type DRUG

CS-002 Topical Treatment

Placebo

Placebo Topical Treatment

Group Type PLACEBO_COMPARATOR

Placebo Topical Solution

Intervention Type DRUG

Placebo Topical Solution

Interventions

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CS-002

CS-002 Topical Treatment

Intervention Type DRUG

Placebo Topical Solution

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No