Acne VulgarisPhase 2/3NCT06787222
Effectiveness and Safety of Zingiber Officinale Transdermal Patch for Acne Vulgaris; Study of Interleukin 1 and Skin Microbiome
A Phase 2/3 study testing tretinoin 0.025% + Z. officinale patch and tretinoin 0.025% cream in people with Acne Vulgaris, run by Hasanuddin University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- tretinoin 0.025% + Z. officinale patch and tretinoin 0.025% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIndonesia
- Study dates
- 3 Nov 2024to 31 Oct 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Indonesia1 site
Doctoral Programme, Faculty of Medicine, Hasanuddin University
Makassar, South Sulawesi
About this study
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.
Read the 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.
- 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.
- Conditions
- Acne Vulgaris
- Being tested
- tretinoin 0.025% + Z. officinale patch, tretinoin 0.025% cream
- Keywords
- acne vulgaris, zingiber officinale, microbiome
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tretinoin 0.025% + Z. officinale patchDrug
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% creamDrug
no Z. officinale patch applied after tretinoin 0.025% application
| Study group | Role | What they receive |
|---|---|---|
| tretinoin 0.025% + Z.officinale patch | Experimental | Z. officinale 0.05% application on pustule after tretinoin 0.025% application Receives: Drug: tretinoin 0.025% + Z. officinale patch |
| tretinoin 0.025% cream | Active comparator | No Z. officinale patch Receives: Drug: tretinoin 0.025% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total inflammatory acne lesions
Total inflammatory acne lesions are the total of papules, pustules, nodules, and cysts.
Measured: At 0 and after 3 weeks duration of trial
Secondary outcomes (2)
Level of Interleukin-1 from pustule
Level of interleukin-1 will be measured using ELISA method
Measured: At 0 and after 3 weeks duration of trial
Skin microbiome
- epidermidis/ C. acnes ratio will be measured using digital Polymerase Chain Reaction
Measured: At 0 and after 3 weeks duration of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start3 Nov 2024
- Primary completion25 Aug 2025
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rini Amanda Carolina Saragih, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787222
- Sponsor's protocol ID
- 700/UN4.6.4.5.31/PP36/2024
- Status last verified
- Nov 2024
- First submitted
- 16 Jan 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33708178Lebeer 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.
PubMed 35243421Wang 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.
PubMed 34576694Byrd 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.
PubMed 29332945Aji, 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
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.
PubMed 35188051Jaturapisanukul 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.
PubMed 33651470Franco 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.
PubMed 32414187Elias 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.
PubMed 34173265
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Zingiber Officinale Transdermal Patch for Acne Vulgaris; Study of Interleukin 1 and Skin Microbiome
- ClinicalTrials.gov ID
- NCT06787222
- Acronym / sponsor ID
- 700/UN4.6.4.5.31/PP36/2024
- Conditions
- Acne Vulgaris
- Keywords
- acne vulgaris, zingiber officinale, microbiome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 3 Nov 2024 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| tretinoin 0.025% + Z.officinale patch | Experimental | Drug: tretinoin 0.025% + Z. officinale patchZ. officinale 0.05% application on pustule after tretinoin 0.025% application |
| tretinoin 0.025% cream | Active comparator | Drug: tretinoin 0.025% creamNo Z. officinale patch |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tretinoin 0.025% + Z. officinale patchMaterial 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. | Drug | tretinoin 0.025% + Z.officinale patch |
| tretinoin 0.025% creamno Z. officinale patch applied after tretinoin 0.025% application | Drug | tretinoin 0.025% cream |
Primary outcome
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.
2 secondary outcomes
Level of Interleukin-1 from pustule
Time frame: At 0 and after 3 weeks duration of trial
Skin microbiome
Time frame: At 0 and after 3 weeks duration of trial
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Background: PubMed 33708178Wang 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.
- Background: PubMed 35243421Lebeer 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.
- Background: PubMed 34576694Wang 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.
- Background: PubMed 29332945Byrd 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.
- BackgroundAji, 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: PubMed 35188051Kondapalli 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.
- Background: PubMed 33651470Jaturapisanukul 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.
- Background: PubMed 32414187Franco 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.
- Background: PubMed 34173265Elias 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing tretinoin 0.025% + Z. officinale patch and tretinoin 0.025% cream in people with Acne Vulgaris, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total inflammatory acne lesions (time frame: At 0 and after 3 weeks duration of trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06787222, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.