NCT06422026

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

11 months

First QC Date

May 15, 2024

Last Update Submit

May 21, 2024

Conditions

Hair Damage

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in hair tensile strength

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

    Baseline, 24 week

Secondary Outcomes (6)

  • Change from baseline in hair gloss

    Baseline, 24 week

  • Change from baseline in hair density

    Baseline, 24 week

  • Change from baseline in hair volume

    Baseline, 24 week

  • Change from baseline in satisfaction survey

    Baseline, 24 week

  • Change from baseline in scalp moisture

    Baseline, 24 week

  • +1 more secondary outcomes

Study Arms (3)

APCP I

ACTIVE COMPARATOR
Dietary Supplement: APCP I

APCP II

ACTIVE COMPARATOR
Dietary Supplement: APCP II

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

APCP IDIETARY_SUPPLEMENT

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

APCP I
APCP IIDIETARY_SUPPLEMENT

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

APCP II
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2024

First Posted

May 20, 2024

Study Start

March 16, 2023

Primary Completion

January 30, 2024

Study Completion

April 30, 2024

Last Updated

May 22, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)