NCT06657352

Brief Summary

This project aims to conduct safety and efficacy tests on the skin for the ingestion of Astrion Vitality Capsules, containing A. membranaceus and C. Asiatica roots, and the topical application of Astrion Vitality Cream. The goal is to develop health and skincare products that regulate physiological functions, promote overall wellness, and enhance skin beauty.

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 Nov 2022

Shorter than P25 for not_applicable

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

November 28, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

10 months

First QC Date

October 23, 2024

Last Update Submit

October 23, 2024

Conditions

Skin PigmentSkin Red

Outcome Measures

Primary Outcomes (6)

  • skin melanin

    Skin elastometer (Soft Plus) was utilized to measure skin melanin. Units: arbitrary units

    The topical group applied ACS cream to the face twice daily for 4 weeks. The oral group took one ACS capsule twice daily after meals for 12 weeks. The combination group followed both regimens for 12 weeks. A placebo group, identical in appearance but wit

  • Skin brightness

    Skin color difference analyzer (Chroma Meter MM500) was utilized to measure skin brightness

    The topical group applied ACS cream to the face twice daily for 4 weeks. The oral group took one ACS capsule twice daily after meals for 12 weeks. The combination group followed both regimens for 12 weeks. A placebo group, identical in appearance but wit

  • skin moisture

    Skin moisture meter (Corneometer CM825) was utilized to measure skin moisture. Units: arbitrary units

    The topical group applied ACS cream to the face twice daily for 4 weeks. The oral group took one ACS capsule twice daily after meals for 12 weeks. The combination group followed both regimens for 12 weeks. A placebo group, identical in appearance but wit

  • skin elasticity

    Skin elastometer (Soft Plus) was utilized to measure skin elasticity. Units: arbitrary units

    The topical group applied ACS cream to the face twice daily for 4 weeks. The oral group took one ACS capsule twice daily after meals for 12 weeks. The combination group followed both regimens for 12 weeks. A placebo group, identical in appearance but wit

  • collagen density content

    Subcutaneous collagen scanner (DermaLab® Series SkinLab Combo) was utilized to measure skin collagen. Units: arbitrary units

    The topical group applied ACS cream to the face twice daily for 4 weeks. The oral group took one ACS capsule twice daily after meals for 12 weeks. The combination group followed both regimens for 12 weeks. A placebo group, identical in appearance but wit

  • skin surface topography

    VISIA Micro-Analysis Skin Image Analyzer was utilized to measure skin texture. Units: arbitrary units

    The topical group applied ACS cream to the face twice daily for 4 weeks. The oral group took one ACS capsule twice daily after meals for 12 weeks. The combination group followed both regimens for 12 weeks. A placebo group, identical in appearance but wit

Study Arms (6)

ACS Topical Treatment Group

EXPERIMENTAL

25 participants, measured at Week 0, 2, 4.

Dietary Supplement: ACS Topical Treatment Group

Topical Placebo Group

PLACEBO COMPARATOR

25 participants, measured at Week 0, 2, 4.

Dietary Supplement: Topical Placebo Group

ACS Oral Treatment Group

EXPERIMENTAL

25 participants, measured at Week 0, 2, 4, 8, 12.

Dietary Supplement: ACS Oral Treatment Group

Oral Placebo Group

PLACEBO COMPARATOR

25 participants, measured at Week 0, 2, 4, 8, 12.

Dietary Supplement: Oral Placebo Group

ACS Oral Treatment + ACS Topical Treatment Group

EXPERIMENTAL

25 participants, measured at Week 0, 2, 4, 8, 12.

Dietary Supplement: Oral Treatment + Topical Treatment Group

ACS Oral Treatment + Topical Placebo Group

PLACEBO COMPARATOR

25 participants, measured at Week 0, 2, 4, 8, 12.

Dietary Supplement: Oral Treatment + Topical Placebo Group

Interventions

ACS Topical Treatment GroupDIETARY_SUPPLEMENT

The topical group applied the ACS cream to the face twice daily (morning and night) for 4 weeks.

ACS Topical Treatment Group
Topical Placebo GroupDIETARY_SUPPLEMENT

The topical group applied the cream (without ACS) to the face twice daily (morning and night) for 4 weeks.

Topical Placebo Group
Oral Treatment + Topical Treatment GroupDIETARY_SUPPLEMENT

The combination group used both the topical and oral ACS products for 12 weeks.

ACS Oral Treatment + ACS Topical Treatment Group
ACS Oral Treatment GroupDIETARY_SUPPLEMENT

The oral group ingested one ACS capsule twice daily after breakfast and dinner for 12 weeks.

ACS Oral Treatment Group
Oral Placebo GroupDIETARY_SUPPLEMENT

The oral group ingested one capsule (without ACS) twice daily after breakfast and dinner for 12 weeks.

Oral Placebo Group
Oral Treatment + Topical Placebo GroupDIETARY_SUPPLEMENT

The combination group used both the topical and oral products without ACS for 12 weeks.

ACS Oral Treatment + Topical Placebo Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects aged ≥18 years.

You may not qualify if:

  • Non-voluntary participants.
  • Subjects diagnosed with skin diseases, cirrhosis, or chronic renal failure by a -physician.
  • Individuals with known allergies to cosmetics, drugs, or food.
  • Pregnant or breastfeeding women.
  • Individuals taking medication for chronic diseases.
  • Subjects who, within 12 weeks prior to the test, have undergone laser facial treatments, chemical peels, or experienced prolonged sun exposure (more than 3 hours of direct sunlight in a week).
  • Students taught by the investigator.
  • Individuals unwilling to allow the publication of photos of the experimental results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chia Nan University of Pharmacy ＆ Science

Tainan, 71710, Taiwan

Location

MeSH Terms

Conditions

Pigmentation DisordersErythema

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2024

First Posted

October 24, 2024

Study Start

November 28, 2022

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

October 26, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)