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NCT Number: NCT06787222

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Doctoral Programme, Faculty of Medicine, Hasanuddin University

Makassar, South Sulawesi, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

tretinoin 0.025% + Z. officinale patch

Drug

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.

tretinoin 0.025% cream

Drug

no Z. officinale patch applied after tretinoin 0.025% application

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Hasanuddin University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2025
Registry last updated
Sep 15, 2025

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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