Clinical Study of DA-002 and DA-005 As a Treatment for Ha... | NCT06501924

Studies
Clinical Study of DA-002 and DA-005 As a Treatment for Hair Loss

NCT06501924

Sponsor

Applied Biology, Inc.

Status

Not yet recruiting

Last Update Posted

Dec 19, 2024Actual

Enrollment

516Estimated

Phase

Phase 3

Conditions

Androgenetic Alopecia
Female Pattern Baldness
Male Pattern Baldness

Interventions

DA-005
Topical minoxidil 5%
DA-002
Placebo Oral Tablet
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

Jan 15, 2025Estimated

Primary Completion Date

Oct 17, 2025Estimated

Completion Date

Dec 12, 2025Estimated

First Submitted Date

Jul 8, 2024

First Submission Date that Met QC Criteria

Jul 12, 2024

First Posted Date

Jul 15, 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 17, 2024

Last Update Posted Date

Dec 19, 2024Actual

Name	Class
Follea International Limited	INDUSTRY
Daniel Alain, Inc.	INDUSTRY

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

The primary objective of the study is to assess the safety and efficacy of DA-005 and DA-002 as a treatment for hair loss (androgenetic alopecia).

Detailed Description

DA-005 is a botanical supplement with demonstrated HIF-1a inhibitory action. The ingredients were tested in-vitro and have demonstrated the HIF-1a inhibitory effect. The primary aim of the study is to compare DA-005 to topical minoxidil in the treatment of hair loss (also known as androgenetic alopecia).

DA-002 is a topical alpha 1 agonist. The ingredients were tested in-vitro and have demonstrated hair growth effects. The secondary aim of the study is to compare DA-002 to topical minoxidil in the treatment of hair loss (also known as androgenetic alopecia).

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

516Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DA-005	Experimental	Oral Botanical Supplement HIF-1a inhibitor	Dietary Supplement: DA-005 Other: Placebo Topical Solution
Topical Minoxidil 5%	Active Comparator	Topical Minoxidil 5%	Drug: Topical minoxidil 5% Dietary Supplement: Placebo Oral Tablet
DA-002	Experimental	Topical Alpha 1 Agonist	Drug: DA-002 Dietary Supplement: Placebo Oral Tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DA-005	Dietary Supplement	Oral Botanical Supplement HIF-1a inhibitor	DA-005

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Target Area Hair Counts	Target Area Hair Counts	Week [0,12]
Target Area Hair Counts	Target Area Hair Counts	Week [0,24]

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 or older
Diagnosed with androgenetic alopecia
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 DA-002 or DA-005
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

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Andy Goren, MD	Contact	16507040850		clincalstudies@appliedbiology.com

Name	Affiliation	Role
Andy Goren, MD	University of Rome G. Marconi	Study Director

Label	URL
Daniel Alain, Inc. - Updated Study Information	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases