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

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ClinicalTrials.gov Identifier: NCT02594046
Recruitment Status : Completed
First Posted : November 1, 2015
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Sang Yeoup Lee, Pusan National University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Androgenic Alopecia Other: stem cell component extract Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of Allogeneic Human Adipose Derived Stem Cell Component Extract on Androgenic Alopecia
Study Start Date : July 1, 2015
Actual Primary Completion Date : February 28, 2016
Actual Study Completion Date : May 28, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Other: stem cell component extract
The Allogeneic Human adipose derived stem cell component extract
Other Name: Tiara hair toninc
Placebo Comparator: placebo group
placebo group who apply a placebo on their scalp for 16 weeks
 Other: stem cell component extract
The Allogeneic Human adipose derived stem cell component extract
Other Name: Tiara hair toninc


Outcome Measures
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Primary Outcome Measures :
  1. change of total hair counts by phototrichogram [ Time Frame: 16 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patient of scalp disease
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Sang Yeoup Lee, professor, Pusan National University Hospital
ClinicalTrials.gov Identifier: NCT02594046    
Other Study ID Numbers: L-2015-199-2
First Posted: November 1, 2015    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical