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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness
• Intervention / Treatment: Drug: Topical minoxidil 5%; Other: Placebo Topical Solution; Dietary supplement: Placebo Oral Tablet; Drug: DA-002; Dietary supplement: DA-005

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).

• Study Type: Interventional
• Enrollment (Estimated): 516
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Andy Goren, MD; Phone Number: 16507040850; Email: clincalstudies@appliedbiology.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Topical Minoxidil 5%	Drug: Topical minoxidil 5%; Topical minoxidil 5%; Dietary supplement: Placebo Oral Tablet; Placebo Oral Tablet
Experimental: DA-002; Topical Alpha 1 Agonist	Dietary supplement: Placebo Oral Tablet; Placebo Oral Tablet; Drug: DA-002; Topical Alpha 1 Agonist (GRAS)
Experimental: DA-005; Oral Botanical Supplement HIF-1a inhibitor	Other: Placebo Topical Solution; Placebo Topical Solution; Dietary supplement: DA-005; Oral Botanical Supplement HIF-1a inhibitor; Other Names: Daniel Alain Botanical Supplement Treatment for Hair Loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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]

Collaborators and Investigators

• Sponsor: Applied Biology, Inc.
• Collaborators: Follea International Limited; Daniel Alain, Inc.
• Investigators: Study Director: Andy Goren, MD, University of Rome G. Marconi

Publications and helpful links

Helpful Links

• Daniel Alain, Inc. - Updated Study Information

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): October 17, 2025
• Study Completion (Estimated): December 12, 2025

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Alopecia Areata; Alopecia; Vasodilator Agents; Antihypertensive Agents; Minoxidil
• Other Study ID Numbers: DA-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No