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Completed

NCT Number: NCT06422026

Evaluated the Efficacy and Safety of APCP on Hair Health

This study is designed to evaluate the efficacy and safety of APCP in promoting hair health in adult with mild to moderate hair damage, compared to a placebo control.

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Key information

Conditions

Hair Damage

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Glossy scores according to the visual evaluation classification method correspond to 1 point or more and 3 points or less and a total hair damage score of less than 18 points evaluated according to exposure to risk factors
  • A person capable of maintaining the same hair shape and color during this human body application test
  • A person who has agreed to participate in this human application test before the start of the human application test and filled out the Informed Consent Form

Exclusion criteria

  • A person currently being treated for infectious diseases and malignant tumors, including severe cardiovascular system, immune system, respiratory system, hepatometer, kidney and urology system, nervous system, musculoskeletal system, psychosis, skin, etc
  • As of Visit 1, those who currently have dull dermatitis, scalp psoriasis, and scalp infection
  • A person who plans to manage and operate hair supplies, hair products during this human body application test
  • A person who has taken oral Dutasteride or Finasteride within 6 months of visit 1
  • A person who has applied topical hair growth agents, wool, and hair growth agents for the last 1 month (30 days) or more as of Visit 1
  • Those who have been administered systemic steroids, cell death agents, vasodilators, antihypertensive agents, antiepileptic agents, beta receptor blockers, bronchodilators, diuretics, Cimetidine, Diazoxide, Cyclosporine, and Ketoconazole for the last 1 month or more (30 days)
  • A person who has applied topical steroids to the scalp for the last 1 month (30 days) or more as of Visit 1
  • A person who has participated in other interventional clinical trials (including human application tests) within one month (30 days) of visit 1 or plans to participate in other interventional clinical trials (including human application tests) after the start of this human application test
  • A person who is pregnant or who has a plan to become pregnant during the nursing mother or during this human body application test
  • A person who is sensitive to or allergic to food ingredients for this human body application test
  • A person who is deemed inappropriate by the tester for other reasons

Treatment and study plan

APCP I

Dietary Supplement

Each subject takes one active bottle per day for 24 weeks. Each bottle contains APCP 3 g.

APCP II

Dietary Supplement

Each subject takes one active bottle per day for 24 weeks. Each bottle contains APCP 4 g.

Placebo

Dietary Supplement

Each subject takes one active bottle per day for 24 weeks.

Primary outcomes

  1. Change from baseline in hair tensile strength

    Time frame: Baseline, 24 week

    Hair tensile strength measured by UTM(Universal Testing Machine) etc.

Secondary outcomes

  1. Change from baseline in hair gloss

    Time frame: Baseline, 24 week

    Hair gloss measured by Glossymeter etc.

  2. Change from baseline in hair density

    Time frame: Baseline, 24 week

    Hair density measured by Folliscope

  3. Change from baseline in hair volume

    Time frame: Baseline, 24 week

    Hair volume measured by I Max-plus

  4. Change from baseline in satisfaction survey

    Time frame: Baseline, 24 week

    Satisfaction surveys are evaluated on a 10-point scale. Survey items are evaluated on a scale from '0 - Not at all' to '10 - Very much so' (although scoring may be reversed depending on the question).

  5. Change from baseline in scalp moisture

    Time frame: Baseline, 24 week

    scalp moisture measured by DermaLab Hydration Pin Probe

  6. Change from baseline in scalp percutaneous moisture loss

    Time frame: Baseline, 24 week

    scalp percutaneous moisture loss measured by Tewameter TM Nano

Sponsors and collaborators

Lead sponsor

Amorepacific Corporation

Industry

Registry information

Official study title

A 24 Week, Randomized, Double Blind, Placebo Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of APCP on Hair Health

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 20, 2024
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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