The primary objective of the study is to assess the safety and efficacy of DA-001 as a treatment for Hair Shedding Reduction and Hair Re-Growth
DA-001 is a topical alpha 1 agonist combined with a TAAR receptor agonist. DA-001 was studied in a population of women that suffer from excessive hair shedding. DA-001 demonstrated significant reduction in hair shedding. This study aims to assess the safety and efficacy of DA-001 as a treatment for Hair Shedding Reduction and Hair Re-Growth.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
800
Phenylephrine 2.5% Topical + TAAR Agonist (GRAS) Topical Solution
Placebo Topical Solution
Phenylephrine 2.5% Topical
Mean Change in Hair Shedding
Number of hairs shedding during brushing at target area
Time frame: Minutes [0,5]
Mean Change in Hair Shedding
Number of hairs shedding during brushing at target area
Time frame: Week [0, 4, 12, 24]
Mean Change in Target Area Hair Count (TAHC)
Number of hairs in a 1-cm² target scalp area
Time frame: Week [0, 4, 12, 24]
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DA-001 Topical (Phenylephrine 2.5% Topical + TAAR agonist tyramine) + DA-005 Oral (HIF-1α supplement)
Oral Phenylephrine 20 mg + DA-005 Oral (HIF-1α supplement)