The objective of this study is to evaluate the efficacy and safety of ENERGI-F701 Solution in female subjects with hair loss.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
67
ENERGI-F701 are applied for treatment of hair loss.
Regaine are applied for treatment of hair loss.
Taipei Veterans General Hospital
Taipei, Taiwan
The amount of hair loss
Change of the amount of hair loss at Week 12 from baseline.(hair loss is defined as the collection of hairs after combing at the study site)
Time frame: Week 12
The amount of hair loss at each post-treatment visit
Time frame: Week 2, 4, 6, 8, 10
The thickness and density of hair
Change of hair thickness and density measured by phototrichogram at each post-treatment visit
Time frame: Week 2, 4, 6, 8, 10, 12
Investigator assessment at each post-treatment visit
The hair loss will be assessed by the investigator using Investigator Photographic Assessment Questionnaire (IPAQ).The change from Baseline in hair growth will be assessed using the following 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased.
Time frame: Week 2, 4, 6, 8, 10, 12
The hair wash/shed hair count at each post-treatment visit
Subjects will collect hairs full day, including after combing and hair-washing. Subjects should turn in these hair collections at each visit. The results will be averaged weekly.
Time frame: Week 2, 4, 6, 8, 10, 12
The subject satisfaction
Subject satisfaction evaluated by Women's Androgenic Alopecia Quality of Life Questionnaire (WAA-QOL) at each post-treatment visit from baseline. WAA-QOL is a sixteen-question questionnaire to evaluate subjects' quality of life influenced by hair loss. Each question will be assessed using the following 7-point scale: 0 = not at all, 1 = a little bit, 2 = somewhat, 3 = a good bit, 4 = quite a bit , 5 = very much, 6 = extremely.
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Time frame: Week 2, 4, 6, 8, 10, 12