Androgenetic Alopecia, Female Pattern Baldness, Male Pattern Baldness
Conditions
Brief summary
The primary objective of the study is to assess the safety and efficacy of DA-005 and DA-002 as a treatment for hair loss (androgenetic alopecia).
Detailed description
DA-005 is a botanical supplement with demonstrated HIF-1a inhibitory action. The ingredients were tested in-vitro and have demonstrated the HIF-1a inhibitory effect. The primary aim of the study is to compare DA-005 to topical minoxidil in the treatment of hair loss (also known as androgenetic alopecia). DA-002 is a topical alpha 1 agonist. The ingredients were tested in-vitro and have demonstrated hair growth effects. The secondary aim of the study is to compare DA-002 to topical minoxidil in the treatment of hair loss (also known as androgenetic alopecia).
Interventions
DIETARY_SUPPLEMENTDA-005
Oral Botanical Supplement HIF-1a inhibitor
Topical minoxidil 5%
DRUGDA-002
Topical Alpha 1 Agonist (GRAS)
DIETARY_SUPPLEMENTPlacebo Oral Tablet
Placebo Oral Tablet
Placebo Topical Solution
Sponsors
Follea International Limited
Daniel Alain, Inc.
Applied Biology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Diagnosed with androgenetic alopecia * 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-002 or DA-005 * 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 |
Contacts
Primary ContactAndy Goren, MD
Outcome results
None listed