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Not yet recruiting NCT07166354

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

Phase I / Phase II Interventional Canities Grey Hair

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CS-002, Placebo Topical Solution.
Who it may be relevant to
Registry conditions: Canities, Grey Hair. Basic parameters: 30 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed description

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.

Interventions

  • Drug CS-002
    CS-002 Topical Treatment
  • Drug Placebo Topical Solution
    Placebo Topical Solution

Primary outcome measures

  • Greying Severity Score [Time frame: Week [0,24]]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Singal A, Daulatabad D, Grover C. Graying severity score: A useful tool for evaluation of premature canities. Indian Dermatol Online J. 2016 May-Jun;7(3):164-7. doi: 10.4103/2229-5178.182372. PMID 27294049

Identifiers

NCT: NCT07166354 · CS-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗