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

Rajdhevee Holistic Clinic Co., Ltd.0 sites60 target enrollmentJuly 3, 2023

ConditionsHealthy 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

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Healthy adults aged 18 to 40 years (inclusive) diagnosed with Acne Type 3 lesions on the facial area
Sponsor: Rajdhevee Holistic Clinic Co., Ltd.
Enrollment: 60
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 3, 2023

End Date

November 2, 2023

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

Rajdhevee Holistic Clinic Co., Ltd.

Eligibility Criteria

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).