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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 30, 2015
First Posted Date  ICMJE November 1, 2015
Last Update Posted Date April 5, 2017
Study Start Date  ICMJE July 1, 2015
Actual Primary Completion Date February 28, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2015)
change of total hair counts by phototrichogram [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Allogeneic Human Adipose Derived Stem Cell Component Extract on Androgenic Alopecia
Official Title  ICMJE The Effect of Allogeneic Human Adipose Derived Stem Cell Component Extract on Androgenic Alopecia
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Androgenic Alopecia
Intervention  ICMJE Other: stem cell component extract
The Allogeneic Human adipose derived stem cell component extract
Other Name: Tiara hair toninc
Study Arms  ICMJE
  • 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
    Intervention: Other: stem cell component extract
  • Placebo Comparator: placebo group
    placebo group who apply a placebo on their scalp for 16 weeks
    Intervention: Other: stem cell component extract
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2015)
38
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 28, 2016
Actual Primary Completion Date February 28, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • patient of scalp disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02594046
Other Study ID Numbers  ICMJE L-2015-199-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sang Yeoup Lee, Pusan National University Hospital
Study Sponsor  ICMJE Pusan National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pusan National University Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP