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

Primary Purpose

Androgenic Alopecia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
stem cell component extract
Sponsored by
Pusan National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Androgenic Alopecia

Eligibility Criteria

19 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • patient of scalp disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    stem cell group

    placebo group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    change of total hair counts by phototrichogram

    Secondary Outcome Measures

    Full Information

    First Posted
    October 30, 2015
    Last Updated
    April 3, 2017
    Sponsor
    Pusan National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02594046
    Brief Title
    The Effect of Allogeneic Human Adipose Derived Stem Cell Component Extract on Androgenic Alopecia
    Official Title
    The Effect of Allogeneic Human Adipose Derived Stem Cell Component Extract on Androgenic Alopecia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2015 (undefined)
    Primary Completion Date
    February 28, 2016 (Actual)
    Study Completion Date
    May 28, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pusan National University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Androgenic Alopecia

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    stem cell group
    Arm Type
    Experimental
    Arm Description
    stem cell group who apply 1.2 g of allogeneic human adipose derived stem cell component extract on their scalp for 16 weeks
    Arm Title
    placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    placebo group who apply a placebo on their scalp for 16 weeks
    Intervention Type
    Other
    Intervention Name(s)
    stem cell component extract
    Other Intervention Name(s)
    Tiara hair toninc
    Intervention Description
    The Allogeneic Human adipose derived stem cell component extract
    Primary Outcome Measure Information:
    Title
    change of total hair counts by phototrichogram
    Time Frame
    16 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: androgenic alopecia basic and specific(BASP) classification: M2, C2, U1, V1, or F1 or higher Exclusion Criteria: patient of scalp disease

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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