Clinical Study of Probiotic Treatment for Androgenetic Alopecia

Applied Biology

Status and phase: Withdrawn; Phase 3

Conditions: Female Pattern Baldness; Androgenetic Alopecia

Treatments: Dietary Supplement: Daniel Alain Probiotic Treatment for Androgenetic Alopecia; Drug: Topical minoxidil 5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT06484881

DA-001

Details and patient eligibility

About

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.

Full 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).

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Topical Minoxidil 5% + Multivitamin Oral Supplement

Active Comparator group

Description:

Topical Minoxidil 5% + Multivitamin Oral Supplement

Treatment:

Drug: Topical minoxidil 5%

Placebo Spray + Daniel Alain Probiotic Treatment for Androgenetic Alopecia

Experimental group

Description:

Placebo Spray + Daniel Alain Probiotic Treatment for Androgenetic Alopecia

Treatment:

Dietary Supplement: Daniel Alain Probiotic Treatment for Androgenetic Alopecia