Clinical trial NCT03676400: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Androgenic Alopecia
Keywords: mesenchymal stem cells
conditioned media
NGF-574H
hair growth
androgenic alopecia
paracrine factors
umbilical cord blood
Lead sponsor: Medipost Co Ltd.
Sponsor class: INDUSTRY
First posted: 2018-09-18
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Product group / Control(placebo) group
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in mean total hair density (hair/cm2)
timeFrame: 0, 6, 12 and 24 weeks
measure: Compare visual assessment before and after cosmetic treatment
timeFrame: 0, 6, 12 and 24 weeks
Secondary outcomes:
measure: Change in mean Telogen hair density
timeFrame: 0, 6, 12 and 24 weeks
measure: Change in mean Anagen hair density
timeFrame: 0, 6, 12 and 24 weeks
measure: Change in hair growth speed
timeFrame: 0, 6, 12 and 24 weeks
measure: Change in hair diameter
timeFrame: 0, 6, 12 and 24 weeks
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
state: Chung Nam
Study officials:
affiliation: Dankook University
name: Byungcheol PARK, MD
role: PRINCIPAL_INVESTIGATOR
References: