Effectiveness and Safety of Zingiber Officinale Transdermal Patch for Acne Vulgaris; Study of Interleukin 1 and Skin Microbiome

Phase 2

Recruiting

• Conditions: Acne Vulgaris
• Interventions: Drug: tretinoin 0.025% + Z. officinale patch; Drug: tretinoin 0.025% cream

• Registration Number: NCT06787222
• Lead Sponsor: Hasanuddin University

Brief Summary

The goal of this clinical trial is to investigate the effectivity and safety of mild to moderate acne vulgaris therapy using Zingiber officinale 5 % transdermal patch. Researcher will compare both half faces (split face); one side as treatment side where patch is used, and another side as control. Patient will be asked to apply tretinoin 0,025% cream nightly. After applying tretinoin 0,025% on whole face, patient will be asked to apply patch on a pustule on one half face, and no patch will be used on another half face.

Total lesion count will be assessed before treatment and 21 days after treatment. Specimen for skin microbiome and interleukin examination will be collected before and 21 days after treatment.

Detailed Description

Current acne vulgaris treatment include antibiotic, retinoic acid, and benzoyl peroxide. The use of antibiotic has been linked to antibiotic resistant problem. Research also has shown the association between acne vulgaris and skin microbiome. Therefore, new treatment for acne vulgaris that has good effect on skin microbiome is needed.

Z. officinale is an herb that commonly used in traditional medicine. Researches have shown that it has anti-inflammation activity and antibiotic activity to Cutibacterium acnes. On the other hand, the prebiotic potency of Z. officinale on gut microbiome has also been investigated.

This randomized controlled trial shall include 26 mild to moderate acne vulgaris patients according to inclusion and exclusion criteria. Patches will be given every 5 days as researcher follow up patient condition. Patient photograph will be taken before treatment, on follow up day, and after 21 days treatment. Skin microbiome specimen will be collected using skin swab method. Secret from a chosen pustule will be collected for interleukin examination.

During clinical trial, patient will use non comedogenic sunscreen and soap from researcher. Patient will be asked to report to researcher if there is side effect of treatment.

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-03
• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-01-16
• Study First Posted: 2025-01-22
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27
• Primary Completion: 2025-02-28
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

• female
• 15-45 years old
• mild to moderate acne vulgaris according to Lehmann criteria
• minimal 3 pustules on face that are distributed on right and left sides

Exclusion Criteria

• history of allergy to ingredients that is used in research
• history of topical acne medication and steroid in the last 2 weeks
• history of medical aesthetic procedure such as laser and chemical peeling in the last 2 weeks
• history of oral antibiotic therapy in the last 6 weeks
• history of oral isotretinoin therapy in the last 6 months
• history of probiotic consumption in the last 3 weeks
• pregnancy and lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tretinoin 0.025% + Z.officinale patch	tretinoin 0.025% + Z. officinale patch	Z. officinale 0.05% application on pustule after tretinoin 0.025% application
tretinoin 0.025% cream	tretinoin 0.025% cream	No Z. officinale patch

Primary Outcome Measures

Name	Time	Method
Total inflammatory acne lesions	At 0 and after 3 weeks duration of trial	Total inflammatory acne lesions are the total of papules, pustules, nodules, and cysts.

Secondary Outcome Measures

Name	Time	Method
Level of Interleukin-1 from pustule	At 0 and after 3 weeks duration of trial	Level of interleukin-1 will be measured using ELISA method
Skin microbiome	At 0 and after 3 weeks duration of trial	S. epidermidis/ C. acnes ratio will be measured using digital Polymerase Chain Reaction

Trial Locations

Locations (1)

Doctoral Programme, Faculty of Medicine, Hasanuddin University; 🇮🇩 Makassar, South Sulawesi, Indonesia