CanitiesPhase 3NCT06745336
Clinical Study of CS-001 as a Treatment for Canities (Grey Hair)
A Phase 3 study testing CS-001 in people with Canities and Grey Hair, run by Applied Biology, Inc..
Trial summary
Clinical Study to Assess the Safety and Efficacy of CS-001 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-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2027to 30 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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-001 as a treatment for Canities (Grey Hair)
Read the detailed description
CS-001 is a small molecule that affects lysosomal storage and transfer of melanin from hair follicle melanocytes. In vitro and a small pilot study demonstrated re-pigmentation of grey hair following CS-001 application. The aim of this study is to assess the safety and efficacy of CS-001 as a treatment for grey hair.
- Being tested
- CS-001, Placebo Topical Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS-001Drug
CS-001 Topical Treatment
Placebo Topical SolutionDrug
Placebo Topical Solution
| Study group | Role | What they receive |
|---|---|---|
| CS-001 | Experimental | CS-001 Topical Treatment Receives: Drug: CS-001 |
| 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 [0,52]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start15 Jun 2027 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion30 Dec 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 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
- NCT06745336
- Sponsor's protocol ID
- CS-001
- Status last verified
- Oct 2026
- First submitted
- 17 Dec 2024
- Last updated
- 2 Nov 2026
- 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of CS-001 as a Treatment for Canities (Grey Hair)
- ClinicalTrials.gov ID
- NCT06745336
- Acronym / sponsor ID
- CS-001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Applied Biology, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Complex Science
- Study start
- 15 Jun 2027 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Study to Assess the Safety and Efficacy of CS-001 as a treatment for Canities (Grey Hair)
Detailed description
CS-001 is a small molecule that affects lysosomal storage and transfer of melanin from hair follicle melanocytes. In vitro and a small pilot study demonstrated re-pigmentation of grey hair following CS-001 application. The aim of this study is to assess the safety and efficacy of CS-001 as a treatment for grey hair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CS-001 | Experimental | Drug: CS-001CS-001 Topical Treatment |
| Placebo | Placebo comparator | Drug: Placebo Topical SolutionPlacebo Topical Treatment |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CS-001CS-001 Topical Treatment | Drug | CS-001 |
| Placebo Topical SolutionPlacebo Topical Solution | Drug | Placebo |
Primary outcome
Greying Severity Score
Time frame: Week [0,52]
Greying Severity Score (GSS). Mild Greying score between 0-5, Moderate Greying score between 6-10 and Severe Greying score between 11-15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 27294049Singal 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.
- Individual participant dataSharing planned: No
Related trials for Canities
Not yet recruitingPhase 1/2
Clinical Study of mTOR Inhibitor as a Treatment for Grey Hair (Canities)
Canities, Grey Hair
Recruiting
6-Month Trial of Chinese Herbal Treatments for Hair Loss and Gray Hair
Alopecia, Canities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CS-001 in people with Canities and Grey Hair, run by Applied Biology, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andy Goren, MD (6507040850, clincalstudies@appliedbiology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Greying Severity Score (time frame: Week [0,52]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06745336, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.