Back to resultsHair Up Prospective Study
Primary Purpose
Hair Loss
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hair Up
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hair Loss
Eligibility Criteria
Inclusion Criteria:
- Women who report hair loss during the past 3 months prior to the study
Exclusion Criteria:
- Disorders and medications affecting hair loss/growth, pregnancy, scarring alopecia
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hair Up
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Assessment of hair loss
Pull test
Secondary Outcome Measures
Assessment of hair regrowth
Photographic evaluation of the change in hair density according to the Savin score (scale of 1-mild to 9-severe)
Quality of life questionnaire
Assessment of quality of life byThe Women's Androgenetic Alopecia Quality of Life Questionnaire (WAAQOL)
Full Information
NCT ID
NCT03652701
First Posted
June 27, 2018
Last Updated
April 2, 2019
Sponsor
Shmuel Gonen Technologies Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03652701
Brief Title
Hair Up Prospective Study
Official Title
Hair Up Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
sponsor discretion
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shmuel Gonen Technologies Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The objective of this study is to assess the performance of Hair Up on female pattern hair shedding and regrowth. 58 adult female patients suffering from hair loss will be evaluated in a single center prospective study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hair Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hair Up
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Hair Up
Intervention Description
Herbal topical
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Assessment of hair loss
Description
Pull test
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Assessment of hair regrowth
Description
Photographic evaluation of the change in hair density according to the Savin score (scale of 1-mild to 9-severe)
Time Frame
3 months
Title
Quality of life questionnaire
Description
Assessment of quality of life byThe Women's Androgenetic Alopecia Quality of Life Questionnaire (WAAQOL)
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women who report hair loss during the past 3 months prior to the study
Exclusion Criteria:
Disorders and medications affecting hair loss/growth, pregnancy, scarring alopecia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Hair Up Prospective Study
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