Clinical Study of CS-001 As a Treatment for Canities (Gre... | NCT06745336

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

NCT06745336

Sponsor

Applied Biology, Inc.

Status

Not yet recruiting

Last Update Posted

Dec 24, 2024Actual

Enrollment

240Estimated

Phase

Phase 3

Conditions

Canities
Grey Hair

Interventions

CS-001
Placebo Topical Solution

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2025Estimated

Primary Completion Date

Jun 15, 2027Estimated

Completion Date

Sep 15, 2027Estimated

First Submitted Date

Dec 17, 2024

First Submission Date that Met QC Criteria

Dec 17, 2024

First Posted Date

Dec 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2024

Last Update Posted Date

Dec 24, 2024Actual

Name	Class
Complex Science	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CS-001	Experimental	CS-001 Topical Treatment	Drug: CS-001
Placebo	Placebo Comparator	Placebo Topical Treatment	Drug: Placebo Topical Solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CS-001	Drug	CS-001 Topical Treatment	CS-001
Placebo Topical Solution

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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]

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Andy Goren, MD	Contact	6507040850		clincalstudies@appliedbiology.com

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27294049	Background	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.