NCT02594046

Brief Summary

This randomized, placebo-controlled, double-blind study evaluates the efficacy and tolerability of the allogeneic human adipose derived stem cell component extract on androgenic alopecia in relatively healthy adults. A total of 38 subjects received 1.2 g of allogeneic human adipose derived stem cell component extract per month or a placebo for 16 weeks.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2016

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

8 months

First QC Date

October 30, 2015

Last Update Submit

April 3, 2017

Conditions

Androgenic Alopecia

Outcome Measures

Primary Outcomes (1)

  • change of total hair counts by phototrichogram

    16 weeks

Study Arms (2)

stem cell group

EXPERIMENTAL

stem cell group who apply 1.2 g of allogeneic human adipose derived stem cell component extract on their scalp for 16 weeks

Other: stem cell component extract

placebo group

PLACEBO COMPARATOR

placebo group who apply a placebo on their scalp for 16 weeks

Other: stem cell component extract

Interventions

stem cell component extractOTHER

The Allogeneic Human adipose derived stem cell component extract

Also known as: Tiara hair toninc
placebo groupstem cell group

Eligibility Criteria

Age19 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • androgenic alopecia basic and specific(BASP) classification: M2, C2, U1, V1, or F1 or higher

You may not qualify if:

  • patient of scalp disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 30, 2015

First Posted

November 2, 2015

Study Start

July 1, 2015

Primary Completion

February 28, 2016

Study Completion

May 28, 2016

Last Updated

April 5, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share