Hair Growth Efficacy and Safety of NGF-574H in Adult With Androgenic Alopecia

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Brief Title

Hair Growth Efficacy and Safety of NGF-574H in Adult With Androgenic Alopecia

Official Title

Clinical Study for the Assessment of the Hair Growth Efficacy and Safety of a Cosmetic Investigational Product, After Repeated Applications for 24 Weeks, Under Normal Conditions of Use, in the Asian Adult Subjects With Androgenic Alopecia

Brief Summary

      The purpose of this study is to assess whether cosmetic investigational product containing
      NGF-574H is safe and effective in the treatment of androgenic alopecia in asian adults.
    

Detailed Description

      NGF-574H is a obtained by collection of paracrine factors secreted by human umbilical cord
      blood-derived mesenchymal stem cell that was exposed in vitro to an artificially designed
      environment mimicking alopecia state in hair follicles to prime the composition of the
      paracrine factors optimized for hair growth. This study is to assess and confirm whether
      NGF-574H is safe and effective in the treatment of androgenic alopecia in asian adults.
    


Study Type

Interventional


Primary Outcome

Change in mean total hair density (hair/cm2)

Secondary Outcome

 Change in mean Telogen hair density

Condition

Androgenic Alopecia

Intervention

conditioned media of umbilical cord blood-derived stem cells

Study Arms / Comparison Groups

 NGF-574H
Description:  NGF-574H is hair serum with 5% conditioned media of umbilical cord blood-derived stem cells containing various trophic factors that help alleviate hair loss.
NGF-574H will be directed to use on hair and scalp by subject her/himself at home twice a day (in the morning and evening) for 24 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

84

Start Date

October 2, 2018

Completion Date

July 24, 2019

Primary Completion Date

July 22, 2019

Eligibility Criteria

        Inclusion Criteria:

          1. Origin: Asian (Korean)

          2. Age: adult from 18 to 60 years old

          3. Sex: female (minimum 70) and male

          4. Understanding of the language spoken in the research center: subjects able to read the
             documents they are presented with and to hold to what they are explained.

          5. Social cover: subjects having medical coverage

          6. Subjects whose state of health, at the moment of inclusion, (auto-questionnaires and
             medical examinations for the recruitment, selection and inclusion), are compatible
             with this type of study.

          7. Subjects can be pursuit and observation during the study period.

          8. Subjects have a "hair loss grade" as below criteria:

               -  BASP grade: Basic type (M2 to M3, or C2 to C3, or U1 to U3) or Specific type (V1
                  to V3, or F1 to F3)

               -  For female: Ludwig grade: Ⅰ to Ⅱ

               -  For male: Norwood-Hamilton grade: III to IV

               -  Hair density by phototrichogram: 60 to 190 hair/cm2

               -  Telogen hair ≥ 5%

          9. Subject with hair length ≥3cm in the vertex region and intending to keep this minimum
             length during the whole study period.

         10. Subject accepting the constraints of the phototrichogram technique, i.e. agreeing to
             have 1 shaved zone of 1.5cm2 on the scalp.

         11. Subject agreeing not to apply any topical treatment (other than the investigational
             product) or take any oral product or nutritional supplementation, or have any diet
             known to improve scalp and/or hair qualities or reduce hair loss during the whole
             study period.

         12. Subject agreeing to use a neutral shampoo (subject's own shampoo)

         13. Subject agrees to have a tattoo on the scalp on phototrichogram evaluation area.

         14. Subject presenting preferably with chestnut brown, dark or black hair (in order to
             avoid problems of contrast)

        Exclusion Criteria:

          1. Subject deprived from liberty by a judiciary or administrative decision, sick subject
             in situation of emergency.

          2. Under age or off age subject protected by law, as well as those admitted to sanitary
             or social facilities, ever since the research can be performed in another manner.

          3. Subject who cannot be contacted in case of emergency.

          4. Females in pregnancy (positive urine pregnancy-tests performed at screening(visit 1
             and visit 9)or nursing or without effective contraception method.

          5. Subject with any systemic disorder or skin disease (e.g. scalp disorders such as
             seborrheic dermatitis or scalp psoriasis) or presenting genetic or hormonal alopecia.

          6. Subject with a condition or receiving a medication which, in the opinion of the
             investigator, could compromise the safety of the subject or affect the outcome of the
             study.

          7. Subject using topic cosmetic treatment or oral nutritional supplement likely to
             interfere on hair loss parameters during the last 3 months prior to the start of the
             study (screening)

          8. Subject having a medical treatment likely to induce an alopecia or hypertrichosia, or
             having stopped it from than 3 months (including prostaglandins, rubefacients agents,
             all vasodilators, anti-androgens, all local hormonal treatment, etc...)

          9. Subject following a long period (>30 days) treatment of anti-inflammatory during the
             last 4 months before the start of the study (screening)

         10. Subject following a short period (<30 days) treatment of anti-inflammatory stopped or
             ongoing preceding the screening period.

         11. Subject having a immunosuppressive and/or corticoids treatment during the 4 weeks
             preceding the screening period

         12. Subject having dyed, bleached hair or with a permanent wave prior to study start.

         13. Subject who have been exposed to excessive or intensive UV light (natural or
             artificial) prior to the study.
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Byungcheol PARK, MD, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT03676400

Organization ID

MP-CM-001


Responsible Party

Sponsor

Study Sponsor

Medipost Co Ltd.


Study Sponsor

Byungcheol PARK, MD, Principal Investigator, Dankook University


Verification Date

August 2019