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

NCT03676400 | Completed

• 1 other identifier: MP-CM-001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenic Alopecia

Keywords

mesenchymal stem cells; conditioned media; NGF-574H; hair growth; androgenic alopecia; paracrine factors; umbilical cord blood

Outcome Measures

Primary Outcomes (2)

• Change in mean total hair density (hair/cm2)

  * The hair density by phototrichogram for 24 weeks application, in comparison to initial value (baseline) and/or placebo product. * Measurement of hair density by phototrichogram (Canfield): change in mean total hair density (hair/cm\^2) * Statistical analysis: Time and product effects (p\<0.05)

  0, 6, 12 and 24 weeks

• Compare visual assessment before and after cosmetic treatment

  Visual Assessment using the clinical picture by an investigator: 7 point score (-3 to 3) Visual assessment by a subject (Self-Assessment): 7 point score (-3 to 3)

  0, 6, 12 and 24 weeks

Secondary Outcomes (4)

• Change in mean Telogen hair density

  0, 6, 12 and 24 weeks

• Change in mean Anagen hair density

  0, 6, 12 and 24 weeks

• Change in hair growth speed

  0, 6, 12 and 24 weeks

• Change in hair diameter

  0, 6, 12 and 24 weeks

Study Arms (2)

NGF-574H

EXPERIMENTAL

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.

Other: conditioned media of umbilical cord blood-derived stem cells

placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

conditioned media of umbilical cord blood-derived stem cells OTHER

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

Also known as: NGF-574H

NGF-574H

Placebo OTHER

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

placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Origin: Asian (Korean)
• Age: adult from 18 to 60 years old
• Sex: female (minimum 70) and male
• 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.
• Social cover: subjects having medical coverage
• Subjects can be pursuit and observation during the study period.
• 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%
• Subject with hair length ≥3cm in the vertex region and intending to keep this minimum length during the whole study period.
• Subject accepting the constraints of the phototrichogram technique, i.e. agreeing to have 1 shaved zone of 1.5cm2 on the scalp.
• 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.

You may not qualify if:

• Subject deprived from liberty by a judiciary or administrative decision, sick subject in situation of emergency.
• 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.
• Subject who cannot be contacted in case of emergency.
• Females in pregnancy (positive urine pregnancy-tests performed at screening(visit 1 and visit 9)or nursing or without effective contraception method.
• 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.
• 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.
• 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)
• 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...)
• Subject following a long period (\>30 days) treatment of anti-inflammatory during the last 4 months before the start of the study (screening)
• Subject following a short period (\<30 days) treatment of anti-inflammatory stopped or ongoing preceding the screening period.
• Subject having a immunosuppressive and/or corticoids treatment during the 4 weeks preceding the screening period
• Subject having dyed, bleached hair or with a permanent wave prior to study start.
• Subject who have been exposed to excessive or intensive UV light (natural or artificial) prior to the study.

Sponsors & Collaborators

• Medipost Co Ltd.: lead

Study Sites (1)

Dankook University Hospital

Cheonan, Chung Nam, 31116, South Korea

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Byungcheol PARK, MD

  Dankook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Product group / Control(placebo) group

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 18, 2018
• Study Start: October 2, 2018
• Primary Completion: July 22, 2019
• Study Completion: July 24, 2019
• Last Updated: August 12, 2019

Record last verified: 2019-08

Locations

KR (1)