| Registry | NCT07166354 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 100 (Estimated) |
| Sponsor | Applied Biology, Inc. (Industry); collaborators: Complex Science |
| Conditions | Canities, Grey Hair |
| Interventions | CS-002, Placebo Topical Solution (Drug) |
| Dates | start 2025-10-01 (estimated), primary completion 2027-06-15 (estimated), completion 2027-09-15 (estimated), first posted 2025-09-10, last updated 2025-09-10 |
Related Papers Related Patents Related Grants Related Experts
All trials for Canities All trials for Grey Hair All trials of CS-002 All trials of Placebo Topical Solution
Clinical Study to Assess the Safety and Efficacy of CS-002 (mTOR inhibitor) as a treatment for Canities (Grey Hair)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| CS-002 | Experimental | Drug: CS-002 | CS-002 Topical Treatment |
| Placebo | Placebo comparator | Drug: Placebo Topical Solution | Placebo Topical Treatment |
Sex: All, ages: 30 Years to 65 Years
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