Clinical Study of Probiotic Treatment for Androgenetic Alopecia

NCT06484881 | Withdrawn Phase 3

• 1 other identifier: DA-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Androgenetic Alopecia; Female Pattern Baldness

Outcome Measures

Primary Outcomes (1)

• Target Area Hair Counts

  Target Area Hair Counts

  Week [0,12]

Study Arms (2)

Topical Minoxidil 5% + Multivitamin Oral Supplement

ACTIVE COMPARATOR

Topical Minoxidil 5% + Multivitamin Oral Supplement

Drug: Topical minoxidil 5%

Placebo Spray + Daniel Alain Probiotic Treatment for Androgenetic Alopecia

EXPERIMENTAL

Placebo Spray + Daniel Alain Probiotic Treatment for Androgenetic Alopecia

Dietary Supplement: Daniel Alain Probiotic Treatment for Androgenetic Alopecia

Interventions

Daniel Alain Probiotic Treatment for Androgenetic Alopecia DIETARY_SUPPLEMENT

Probiotic

Placebo Spray + Daniel Alain Probiotic Treatment for Androgenetic Alopecia

Topical minoxidil 5% DRUG

Topical minoxidil 5%

Topical Minoxidil 5% + Multivitamin Oral Supplement

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female subjects 18 and above
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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-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

Sponsors & Collaborators

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

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

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: PRINCIPAL INVESTIGATOR
• PI Title: Study Supervisor

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: September 15, 2024
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share