Hair Up Prospective Study

April 2, 2019 updated by: Shmuel Gonen Technologies Ltd.
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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Other: Placebo
Placebo
EXPERIMENTAL: Hair Up
Other: Hair Up
Herbal topical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of hair loss
Time Frame: 1 month
Pull test
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of hair regrowth
Time Frame: 3 months
Photographic evaluation of the change in hair density according to the Savin score (scale of 1-mild to 9-severe)
3 months
Quality of life questionnaire
Time Frame: 3 months
Assessment of quality of life byThe Women's Androgenetic Alopecia Quality of Life Questionnaire (WAAQOL)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shmuel Gonen Technologies Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2019

Primary Completion (ANTICIPATED)

March 1, 2020

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

June 27, 2018

First Submitted That Met QC Criteria

August 28, 2018

First Posted (ACTUAL)

August 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLPR-001-0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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