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

NCT06501924 | Not Yet Recruiting Phase 3

• 1 other identifier: DA-005
• Study Type: interventional
• Target: 516
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Androgenetic Alopecia; Female Pattern Baldness; Male Pattern Baldness

Outcome Measures

Primary Outcomes (2)

• Target Area Hair Counts

  Target Area Hair Counts

  Week [0,12]

• Target Area Hair Counts

  Target Area Hair Counts

  Week [0,24]

Study Arms (3)

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

DA-005 DIETARY_SUPPLEMENT

Oral Botanical Supplement HIF-1a inhibitor

Also known as: Daniel Alain Botanical Supplement Treatment for Hair Loss

DA-005

Topical minoxidil 5% DRUG

Topical minoxidil 5%

Topical Minoxidil 5%

DA-002 DRUG

Topical Alpha 1 Agonist (GRAS)

DA-002

Placebo Oral Tablet DIETARY_SUPPLEMENT

Placebo Oral Tablet

DA-002; Topical Minoxidil 5%

Placebo Topical Solution OTHER

Placebo Topical Solution

DA-005

Eligibility Criteria

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

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Applied Biology, Inc.: lead
• Follea International Limited: collaborator
• Daniel Alain, Inc.: collaborator

Related Links

• Daniel Alain, Inc. - Updated Study Information

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Andy Goren, MD

  University of Rome G. Marconi

  STUDY DIRECTOR

Central Study Contacts

Andy Goren, MD

CONTACT

16507040850; clincalstudies@appliedbiology.com

Study Design

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

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: January 15, 2025
• Primary Completion: October 17, 2025
• Study Completion: December 12, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share