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

September 9, 2025 updated by: Rini Amanda Carolina Saragih, Hasanuddin University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Estimated)

26

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • South Sulawesi
      • Makassar, South Sulawesi, Indonesia
        • Doctoral Programme, Faculty of Medicine, Hasanuddin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tretinoin 0.025% + Z.officinale patch
Z. officinale 0.05% application on pustule after tretinoin 0.025% application
Drug: tretinoin 0.025% + Z. officinale patch
Material used for patch formulation were 3,15 grams of polyvinyl alcohol, 4,2 grams of polyvinyl pyrrolidone, 12,6 ml distilled water, and 1,05 grams of Z. officinale extract.
Active Comparator: tretinoin 0.025% cream
No Z. officinale patch
Drug: tretinoin 0.025% cream
no Z. officinale patch applied after tretinoin 0.025% application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total inflammatory acne lesions
Time Frame: At 0 and after 3 weeks duration of trial
Total inflammatory acne lesions are the total of papules, pustules, nodules, and cysts.
At 0 and after 3 weeks duration of trial

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasanuddin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2024

Primary Completion (Actual)

August 25, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

January 22, 2025

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 700/UN4.6.4.5.31/PP36/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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