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

NCT06787222 | Active Not Recruiting Phase 2

• 1 other identifier: 700/UN4.6.4.5.31/PP36/2024
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Keywords

acne vulgaris, zingiber officinale, microbiome

Outcome Measures

Primary Outcomes (1)

• Total inflammatory acne lesions

  Total inflammatory acne lesions are the total of papules, pustules, nodules, and cysts.

  At 0 and after 3 weeks duration of trial

Secondary Outcomes (2)

• Level of Interleukin-1 from pustule

  At 0 and after 3 weeks duration of trial

• Skin microbiome

  At 0 and after 3 weeks duration of trial

Study Arms (2)

tretinoin 0.025% + Z.officinale patch

EXPERIMENTAL

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

Drug: tretinoin 0.025% + Z. officinale patch

tretinoin 0.025% cream

ACTIVE COMPARATOR

No Z. officinale patch

Drug: tretinoin 0.025% cream

Interventions

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% + Z.officinale patch

tretinoin 0.025% cream DRUG

no Z. officinale patch applied after tretinoin 0.025% application

tretinoin 0.025% cream

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Doctoral Programme, Faculty of Medicine, Hasanuddin University

Makassar, South Sulawesi, Indonesia

Location

Related Publications (9)

• Wang X, Zhang D, Jiang H, Zhang S, Pang X, Gao S, Zhang H, Zhang S, Xiao Q, Chen L, Wang S, Qi D, Li Y. Gut Microbiota Variation With Short-Term Intake of Ginger Juice on Human Health. Front Microbiol. 2021 Feb 23;11:576061. doi: 10.3389/fmicb.2020.576061. eCollection 2020.

  PMID: 33708178 BACKGROUND

• Lebeer S, Oerlemans EFM, Claes I, Henkens T, Delanghe L, Wuyts S, Spacova I, van den Broek MFL, Tuyaerts I, Wittouck S, De Boeck I, Allonsius CN, Kiekens F, Lambert J. Selective targeting of skin pathobionts and inflammation with topically applied lactobacilli. Cell Rep Med. 2022 Feb 15;3(2):100521. doi: 10.1016/j.xcrm.2022.100521. eCollection 2022 Feb 15.

  PMID: 35243421 BACKGROUND

• Wang X, Howe S, Deng F, Zhao J. Current Applications of Absolute Bacterial Quantification in Microbiome Studies and Decision-Making Regarding Different Biological Questions. Microorganisms. 2021 Aug 24;9(9):1797. doi: 10.3390/microorganisms9091797.

  PMID: 34576694 BACKGROUND

• Byrd AL, Belkaid Y, Segre JA. The human skin microbiome. Nat Rev Microbiol. 2018 Mar;16(3):143-155. doi: 10.1038/nrmicro.2017.157. Epub 2018 Jan 15.

  PMID: 29332945 BACKGROUND

• Aji, N., Kumala, S., Mumpuni, E., & Rahmat, D. (2022). Antibacterial Activity and Active Fraction of Zingiber officinale Roscoe, Zingiber montanum (J.Koenig) Link ex A., and Zingiber zerumbet (L.) Roscoe ex Sm. Against Propionibacterium acnes. Pharmacognosy Journal, 14(1), 103-111

  BACKGROUND

• Kondapalli NB, Hemalatha R, Uppala S, Yathapu SR, Mohammed S, Venkata Surekha M, Rajendran A, Bharadwaj DK. Ocimum sanctum, Zingiber officinale, and Piper nigrum extracts and their effects on gut microbiota modulations (prebiotic potential), basal inflammatory markers and lipid levels: oral supplementation study in healthy rats. Pharm Biol. 2022 Dec;60(1):437-450. doi: 10.1080/13880209.2022.2033797.

  PMID: 35188051 BACKGROUND

• Jaturapisanukul K, Udompataikul M, Kanokrungsee S, Rojhirunsakool S, Kamanamool N, Rachpirom M, Puttarak P. Efficacy and safety of a novel water-soluble herbal patch for acne vulgaris treatment: A randomized, assessor-blinds controlled, intra-individual split-face comparative study. Dermatol Ther. 2021 May;34(3):e14925. doi: 10.1111/dth.14925. Epub 2021 Mar 14.

  PMID: 33651470 BACKGROUND

• Franco P, De Marco I. The Use of Poly(N-vinyl pyrrolidone) in the Delivery of Drugs: A Review. Polymers (Basel). 2020 May 13;12(5):1114. doi: 10.3390/polym12051114.

  PMID: 32414187 BACKGROUND

• Elias AE, McBain AJ, O'Neill CA. The role of the skin microbiota in the modulation of cutaneous inflammation-Lessons from the gut. Exp Dermatol. 2021 Oct;30(10):1509-1516. doi: 10.1111/exd.14420. Epub 2021 Jul 11.

  PMID: 34173265 BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Tretinoin

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 22, 2025
• Study Start: November 3, 2024
• Primary Completion: August 25, 2025
• Study Completion: October 31, 2025
• Last Updated: September 15, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)