Hair Up Prospective Study | NCT03652701

Studies
Hair Up Prospective Study

NCT03652701

Sponsor

Shmuel Gonen Technologies Ltd.

Status

Withdrawn

Last Update Posted

Apr 4, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Hair Loss

Interventions

Hair Up
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

sponsor discretion

Expanded Access Info

Start Date

Apr 1, 2019Estimated

Primary Completion Date

Mar 1, 2020Estimated

Completion Date

Mar 1, 2021Estimated

First Submitted Date

Jun 27, 2018

First Submission Date that Met QC Criteria

Aug 28, 2018

First Posted Date

Aug 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2019

Last Update Posted Date

Apr 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hair Up	Experimental		Other: Hair Up
Placebo	Placebo Comparator		Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hair Up	Other	Herbal topical	Hair Up
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Assessment of hair regrowth	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	Assessment of quality of life byThe Women's Androgenetic Alopecia Quality of Life Questionnaire (WAAQOL)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000505	Alopecia

Ancestor Terms

ID	Term
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

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Browse Branches

Not provided