Clinical Study of Probiotic Treatment for Androgenetic Alopecia

October 11, 2024 updated by: Monica Naegle, Applied Biology, Inc.
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Topical Minoxidil 5% + Multivitamin Oral Supplement
Drug: Topical minoxidil 5%
Topical minoxidil 5%
Experimental: Placebo Spray + Daniel Alain Probiotic Treatment for Androgenetic Alopecia
Dietary supplement: Daniel Alain Probiotic Treatment for Androgenetic Alopecia
Probiotic

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Applied Biology, Inc.

Collaborators

Follea International Limited

Investigators

  • Study Director: Andy Goren, MD, University of Rome G. Marconi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2024

Primary Completion (Actual)

October 10, 2024

Study Completion (Actual)

October 10, 2024

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA-001

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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