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The Effect of Allogeneic Human Adipose Derived Stem Cell Component Extract on Androgenic Alopecia

NCT ID: NCT02594046

Last Updated: 2017-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-01

Study Completion Date

2016-05-28

Brief Summary

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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.

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Detailed Description

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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. Hair count and thickness will be primary outcomes.

Conditions

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Androgenic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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stem cell group

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

Group Type EXPERIMENTAL

stem cell component extract

Intervention Type OTHER

The Allogeneic Human adipose derived stem cell component extract

placebo group

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

Group Type PLACEBO_COMPARATOR

stem cell component extract

Intervention Type OTHER

The Allogeneic Human adipose derived stem cell component extract

Interventions

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stem cell component extract

The Allogeneic Human adipose derived stem cell component extract

Intervention Type OTHER

Other Intervention Names

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Tiara hair toninc

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patient of scalp disease
Minimum Eligible Age

19 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pusan National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sang Yeoup Lee

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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L-2015-199-2

Identifier Type: -

Identifier Source: org_study_id

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