A Randomised, Double-blinded, Placebo-controlled Trial to investigate the Efficacy and Safety of Act 3 on the Treatment of Acne Type 3 Lesions

Phase 4

Completed

• Conditions: Healthy adults aged 18 to 40 years (inclusive) diagnosed with Acne Type 3 lesions on the facial area; Acne Type 3; Facial Image Assessment; Nicotinamide; Camellia Sinensis Leaf

• Registration Number: TCTR20230703006
• Lead Sponsor: Rajdhevee Holistic Clinic Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-03
• Study Completion: 2023-11-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Healthy participant between 18 to 40 years old (inclusive).
2. Diagnosed with moderate1 facial Acne Type 3, characterised by inflamed
erythematous papules and papulopustular lesions2.
3. Must give informed consent prior to study enrolment and all study procedures.
4. Must be able to comply with study procedures and be available for all study visits.
5. Must be in general good health based on medical history as determined by the investigator(s) at Screening.

Exclusion Criteria

1. Participants not diagnosed with moderate facial Acne Type 3.
2. Previous use of oral or topical Vitamin A acid (isotretinoin) within 3 months prior to Screening (Day -3).
3. Previous use of topical and systemic antibiotics within 1 month prior to Screening (Day -3).
4. Previous use of laser therapy within 1 month prior to Screening (Day -3).
5. Previous use of hormone therapy, steroids, or anti-inflammatory medicines within 1 month prior to Screening (Day -3), e.g., oral hormones, anti-androgen therapy, spironolactone, steroids, anti-inflammatory medicines.
6. Presence of self-reported or medically documented significant medical or psychiatric condition(s) as judged by the investigator(s) that it may not be in the participants interest to participate in the study.
7. History of severe allergy (requiring hospital care), anaphylaxis, severe reaction to any drug, or any known or suspected allergies or sensitivities to any component of the Study Drug or Placebo.
8. History of alcohol or drug abuse that, in the opinion of the PI(s), could affect the participant safety or compliance with study.
9. Presence of an acute illness, as determined by the PI(s), with or without fever (forehead temperature measured with validated device greater than or equal to 37.5 degree Celsius) at Screening (Day-3) or Enrolment (Day 0).
10. Current use of any prescription or over-the-counter medicines within 7 days prior to Screening (Day -3), unless approved and documented by the PI(s).
11. Use of any other therapeutic or cosmetic products, devices or procedures that could interfere with the assessments of the treatment areas within 7 days prior to Screening (Day -3), unless approved and documented by the PI(s).
12. Current participation in any other interventional clinical trial or previously enrolled in an interventional clinical trial, which in the opinion of the PI(s) may interfere with the interpretation of the trial results.
13. Close affiliation with the PI(s), person(s) working at the trial site(s) or an employee of the sponsor (e.g., a close relative).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subsided Acne Type 3 lesions on Day 8 compared to baseline and Placebo The number and percentage of significantly subsided Acne Type 3 lesions in participants, assessed by examination by physician combined with the facial image analyser (FIA).,flattening of lesions on Day 4 and Day 8 a qualitative questionnaire self assessment

Secondary Outcome Measures

Name	Time	Method
post acne erythema occurrence after lesions on Day 8 and Week 4 compared to baseline and Placebo The number and percentage of Acne Type 3 lesions with post acne erythema occurrence in participants, assessed by examination by physician combined with the FIA.,post inflammatory hyperpigmentation after lesions have completely subsided on Day8 and Week 4 The number and percentage of Acne Type 3 lesions with post inflammatory hyperpigmentation occurrence in participants assessed by examination by physician combined with the FIA.