Clinical Study of Probiotic Treatment for Androgenetic Alopecia

Phase 3

Withdrawn

• Conditions: Androgenetic Alopecia; Female Pattern Baldness
• Interventions: Drug: Topical minoxidil 5%; Dietary Supplement: Daniel Alain Probiotic Treatment for Androgenetic Alopecia

• Registration Number: NCT06484881
• Lead Sponsor: Applied Biology, Inc.

Brief Summary

The primary objective of the study is to assess the efficacy of DA-001 as an oral supplement for treatment of female pattern hair loss.

Detailed Description

DA-001 is a botanical supplement demonstrated natural ingredients known to exert anti-androgen effects. The ingredients were tested in-vitro and have demonstrated the anti-androgen effect. This study aims to compare DA-001 to topical minoxidil in the treatment of female pattern hair loss (also known as androgenetic alopecia).

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-26
• Study First Submitted QC: 2024-06-26
• Study First Posted: 2024-07-03
• Study Start: 2024-09-15
• Primary Completion: 2024-10-10
• Study Completion: 2024-10-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Females Age 18 or older
• Diagnosed with female pattern hair loss
• 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-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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical Minoxidil 5% + Multivitamin Oral Supplement	Topical minoxidil 5%	Topical Minoxidil 5% + Multivitamin Oral Supplement
Placebo Spray + Daniel Alain Probiotic Treatment for Androgenetic Alopecia	Daniel Alain Probiotic Treatment for Androgenetic Alopecia	Placebo Spray + Daniel Alain Probiotic Treatment for Androgenetic Alopecia

Primary Outcome Measures

Name	Time	Method
Target Area Hair Counts	Week [0,12]	Target Area Hair Counts