Efficacy of Nutrition Supplement for Treatment of Men With Hair Loss
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|ClinicalTrials.gov Identifier: NCT02150187|
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : July 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Androgenetic Alopecia||Dietary Supplement: HCap Formula Dietary Supplement: Placebo||Phase 2|
This study consists of a treatment phase (6 months) and a follow-up phase (6 month ). Eligible subjects will be randomly assigned to receive treatment with the study medication or placebo. Subjects will visit the clinic at 3, 6, and 12 months after treatment start for safety and efficacy evaluations.
HCap Formula or placebo tablets will be taken orally every other day during 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Evaluation of the Efficacy of Hcap Formula Nutrition Supplement for Treatment of Men With Androgenic Alopecia: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||May 2015|
Experimental: HCap Formula
Pill of HCap Formula every other day for 6 month during the treatment phase; Follow up phase: nothing.
Dietary Supplement: HCap Formula
Pill should be taken every other day during the treatment phase.
Placebo Comparator: Placebo
Same as treatment with placebo pills
Dietary Supplement: Placebo
Similar pills without active ingredients
- Changes in Terminal Hair Count at 26 Weeks Compared to Baseline [ Time Frame: Baseline, 26 Weeks ]The primary outcome will be change in the terminal hair count from baseline to 26 Weeks within a 3 cm diameter circle based on macro-photographs of the same area. The treatment group will be compared to the control.
- Global Assessment of Improvement from Baseline to 26 and 52 weeks Assessed for Vertex and Frontal Views Separately [ Time Frame: Baseline, 26 weeks, 52 weeks ]Assessment of improvement using a 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3). This assessment will be performed by comparing the global photographs obtained at Baseline with those subsequently obtained at baseline, 26, and 52 weeks. This assessment will be carried out separately on the global photography of the vertex and frontal views
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): NCT02150187
|Dr David Friedman Laser & Skin Center|
|Jerusalem, Israel, 9644035|
|Principal Investigator:||David J Friedman, MD||Friedman Skin & Laser Center|
|Study Director:||Lilach Gavish, PhD||Friedman Skin & Laser Center|