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Clinical Trials/NCT07166354
NCT07166354Not yet recruitingPhase 1

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

Applied Biology, Inc.0 sites100 target enrollmentStarted: October 1, 2025Last updated:
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Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Not yet recruiting
Enrollment
100
Primary Endpoint
Greying Severity Score
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
30 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

CS-002

Experimental

CS-002 Topical Treatment

Intervention: CS-002 (Drug)

Placebo

Placebo Comparator

Placebo Topical Treatment

Intervention: Placebo Topical Solution (Drug)

Outcomes

Primary Outcomes

Greying Severity Score

Time Frame: Week [0,24]

Greying Severity Score (GSS). Mild Greying score between 0-5, Moderate Greying score between 6-10 and Severe Greying score between 11-15

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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