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Completed

NCT Number: NCT06657352

Skin Efficacy Testing of Astrion Products

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.

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Key information

Conditions

Skin Pigment Erythema Pathologic Processes Pathological Conditions, Signs and Symptoms Pigmentation Disorders Signs and Symptoms Skin Diseases Skin Manifestations Skin Red Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chia Nan University of Pharmacy ＆ Science

Tainan, 71710, Taiwan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects aged ≥18 years.

Exclusion criteria

  • 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.

Treatment and study plan

ACS Topical Treatment Group

Dietary Supplement

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

Topical Placebo Group

Dietary Supplement

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

Oral Treatment + Topical Treatment Group

Dietary Supplement

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

ACS Oral Treatment Group

Dietary Supplement

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

Oral Placebo Group

Dietary Supplement

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

Oral Treatment + Topical Placebo Group

Dietary Supplement

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

Primary outcomes

  1. skin melanin

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

  2. Skin brightness

    Time frame: 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 color difference analyzer (Chroma Meter MM500) was utilized to measure skin brightness

  3. skin moisture

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

  4. skin elasticity

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

  5. collagen density content

    Time frame: 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

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

  6. skin surface topography

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Chia Nan University of Pharmacy ＆ Science

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 24, 2024
Registry last updated
Oct 26, 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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