CanitiesPhase 1/2NCT07166354
Clinical Study of mTOR Inhibitor as a Treatment for Grey Hair (Canities)
A Phase 1/2 study testing CS-002 in people with Canities and Grey Hair, run by Applied Biology, Inc..
Trial summary
Clinical Study to Assess the Safety and Efficacy of CS-002 (mTOR inhibitor) as a treatment for Canities (Grey Hair) Read more about this study
- Who is it for?
- Ages 30 to 65 years
- What is being tested?
- CS-002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 15 Sep 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Clinical Study to Assess the Safety and Efficacy of CS-002 (mTOR inhibitor) as a treatment for Canities (Grey Hair)
Read the 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.
- Being tested
- CS-002, Placebo Topical Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS-002Drug
CS-002 Topical Treatment
Placebo Topical SolutionDrug
Placebo Topical Solution
| Study group | Role | What they receive |
|---|---|---|
| CS-002 | Experimental | CS-002 Topical Treatment Receives: Drug: CS-002 |
| Placebo | Placebo comparator | Placebo Topical Treatment Receives: Drug: Placebo Topical Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Greying Severity Score
Greying Severity Score (GSS). Mild Greying score between 0-5, Moderate Greying score between 6-10 and Severe Greying score between 11-15
Measured: Week [0,24]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CanitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Applied Biology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Complex Science
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166354
- Sponsor's protocol ID
- CS-002
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27294049