Taipei Veterans General Hospital
Taipei, Taiwan
NCT Number: NCT03351322
The objective of this study is to evaluate the efficacy and safety of ENERGI-F701 Solution in female subjects with hair loss.
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Notify Me20 year and older
Female
Interventional
Phase 2
Taipei, Taiwan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Any subject meeting any of the exclusion criteria will be excluded from study participation.
ENERGI-F701 are applied for treatment of hair loss.
Regaine are applied for treatment of hair loss.
Time frame: Week 12
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 2, 4, 6, 8, 10
Time frame: Week 2, 4, 6, 8, 10, 12
Change of hair thickness and density measured by phototrichogram at each post-treatment visit
Time frame: Week 2, 4, 6, 8, 10, 12
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
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
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.
Energenesis Biomedical Co., Ltd.
Industry
A Randomized, Double-Blind, Active-controlled, Parallel, Phase II Study to Evaluate Efficacy and Safety of ENERGI-F701 Solution in Female Subjects With Hair Loss
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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