Clinical trial NCT06787222: Effectiveness and Safety of Zingiber Officinale Transdermal Patch for Acne Vulgaris; Study of Interleukin 1 and Skin Microbiome
Official title: Effectiveness and Safety of Zingiber Officinale Transdermal Patch for Acne Vulgaris; Study of Interleukin 1 and Skin Microbiome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Acne Vulgaris
Keywords: acne vulgaris, zingiber officinale, microbiome
Lead sponsor: Hasanuddin University
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 26
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total inflammatory acne lesions
timeFrame: At 0 and after 3 weeks duration of trial
Secondary outcomes:
measure: Level of Interleukin-1 from pustule
timeFrame: At 0 and after 3 weeks duration of trial
measure: Skin microbiome
timeFrame: At 0 and after 3 weeks duration of trial
Other outcomes:
Locations:
city: Makassar
country: Indonesia
facility: Doctoral Programme, Faculty of Medicine, Hasanuddin University
state: South Sulawesi
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.