Androgenetic Alopecia, Female Pattern Baldness
Conditions
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).
Interventions
DIETARY_SUPPLEMENTDaniel Alain Probiotic Treatment for Androgenetic Alopecia
Probiotic
Topical minoxidil 5%
Sponsors
Follea International Limited
Applied Biology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Area Hair Counts | Week [0,12] | Target Area Hair Counts |
Outcome results
None listed