Clinical Study of CS-001 As a Treatment for Canities (Grey Hair)

NCT06745336 | Not Yet Recruiting Phase 3

• 1 other identifier: CS-001
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinical Study to Assess the Safety and Efficacy of CS-001 as a treatment for Canities (Grey Hair)

Conditions

Canities; Grey Hair

Outcome Measures

Primary Outcomes (1)

• 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

  Week [0,52]

Study Arms (2)

CS-001

EXPERIMENTAL

CS-001 Topical Treatment

Drug: CS-001

Placebo

PLACEBO COMPARATOR

Placebo Topical Treatment

Drug: Placebo Topical Solution

Interventions

CS-001 DRUG

CS-001 Topical Treatment

CS-001

Placebo Topical Solution DRUG

Placebo Topical Solution

Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Applied Biology, Inc.: lead
• Complex Science: collaborator

Related Publications (1)

• 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 BACKGROUND

Central Study Contacts

Andy Goren, MD

CONTACT

6507040850; clincalstudies@appliedbiology.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: June 15, 2025
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share