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

NCT ID: NCT03676400

Last Updated: 2019-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-02
• Study Completion Date: 2019-07-24

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.

Conditions

Androgenic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

NGF-574H

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.

Group Type: EXPERIMENTAL

conditioned media of umbilical cord blood-derived stem cells

Intervention Type: OTHER

Hair serum with 5% conditioned media of human umbilical cord blood-derived mesenchymal stem cells

placebo

Hair serum without conditioned media of umbilical cord blood-derived stem cells 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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Hair serum without conditioned media of human umbilical cord blood-derived mesenchymal stem cells

Interventions

conditioned media of umbilical cord blood-derived stem cells

Hair serum with 5% conditioned media of human umbilical cord blood-derived mesenchymal stem cells

Intervention Type: OTHER

Placebo

Hair serum without conditioned media of human umbilical cord blood-derived mesenchymal stem cells

Intervention Type: OTHER

Other Intervention Names

NGF-574H

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medipost Co Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Byungcheol PARK, MD

Role: PRINCIPAL_INVESTIGATOR

Dankook University

Locations

Dankook University Hospital

Cheonan, Chung Nam, South Korea

Countries

South Korea

Other Identifiers

MP-CM-001

Identifier Type: -

Identifier Source: org_study_id