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

Hasanuddin University

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: tretinoin 0.025% cream; Drug: tretinoin 0.025% + Z. officinale patch

Study type: Interventional

Funder types: Other

Identifiers

NCT06787222

700/UN4.6.4.5.31/PP36/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 estimated patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

tretinoin 0.025% + Z.officinale patch

Experimental group

Description:

Z. officinale 0.05% application on pustule after tretinoin 0.025% application

Treatment:

Drug: tretinoin 0.025% + Z. officinale patch

tretinoin 0.025% cream

Active Comparator group

Description:

No Z. officinale patch

Treatment:

Drug: tretinoin 0.025% cream