ENERGI-F701 for Female Hair Loss Treatment
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|ClinicalTrials.gov Identifier: NCT03351322|
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : September 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Female Pattern Baldness Hair Loss Alopecia||Drug: ENERGI-F701 Drug: Regaine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||May 23, 2018|
|Estimated Primary Completion Date :||October 3, 2019|
|Estimated Study Completion Date :||February 3, 2020|
ENERGI-F701, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks
ENERGI-F701 are applied for treatment of hair loss.
Active Comparator: Regaine
Regaine, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks
Regaine are applied for treatment of hair loss.
- The amount 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)
- The amount of hair loss at each post-treatment visit [ Time Frame: Week 2, 4, 6, 8, 10 ]
- The thickness and density of hair [ Time Frame: Week 2, 4, 6, 8, 10, 12 ]Change of hair thickness and density measured by phototrichogram at each post-treatment visit
- Investigator assessment 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.
- The hair wash/shed hair count at each post-treatment visit [ 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.
- The subject satisfaction [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351322
|Contact: Yi-Fang Cheng, PhD.||886-2-2627-0835 ext firstname.lastname@example.org|
|Taipei Veterans General Hospital||Recruiting|
|Contact: Chih-Chiang Chen, MD. PhD. 886-2-2871-2121 ext 3373 email@example.com|
|Principal Investigator: Chih-Chiang Chen, MD. PhD.|