Seborrheic KeratosisANDAL-SKNCT07334600
Effect of 1% Andaliman Fruit Extract Cream on Facial Seborrheic Keratosis
A study testing 1% Andaliman Fruit Extract Cream in people with Seborrheic Keratosis, run by Universitas Sumatera Utara at 1 site in Indonesia.
Trial summary
Seborrheic keratosis is a common benign skin growth that often appears on the face and may cause cosmetic concerns. This study aimed to evaluate the effectiveness and safety of a 1% andaliman fruit extract cream (Zanthoxylum acanthopodium DC.) as a topical treatment for facial seborrheic keratosis. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Seborrheic Keratosis
- What is being tested?
- 1% Andaliman Fruit Extract Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2025to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18-50 years.
- Patients diagnosed with common seborrheic keratosis lesions located on the facial region.
- Diagnosis confirmed by clinical and dermoscopic examination.
- Willing to participate in the study and provide written informed consent.
Who cannot join
- Pregnant or breastfeeding women.
- Use of topical treatments such as 5-fluorouracil, tretinoin, adapalene, glycolic acid, alpha-hydroxy acid, or antioxidants prior to enrollment.
- History of chemical peeling or laser therapy before enrollment.
- Use of oral or injectable antioxidants before or during the study period.
- Non-compliance with study procedures or use of additional therapies during the study period.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Outpatient Clinic, Prof. Dr. Chairuddin Panusunan Lubis Universitas Sumatera Utara Hospital
Medan, North Sumatra, 20154
About this study
Official title: The Effect of 1% Andaliman Fruit Extract Cream (Zanthoxylum Acanthopodium DC.) on Seborrheic Keratosis
Seborrheic keratosis is a common benign skin growth that often appears on the face and may cause cosmetic concerns. This study aimed to evaluate the effectiveness and safety of a 1% andaliman fruit extract cream (Zanthoxylum acanthopodium DC.) as a topical treatment for facial seborrheic keratosis.
The study used a one-group pretest-posttest design and involved adult patients with seborrheic keratosis who received the cream for 12 weeks. Changes in lesion size were measured over time, and participants were monitored for side effects and overall satisfaction. The results of this study are expected to provide evidence on the potential use of a natural topical therapy for improving the appearance of seborrheic keratosis.
Read the detailed description
This study was a quasi-experimental clinical trial using a one-group pretest-posttest design to evaluate the effect of a 1% andaliman fruit extract cream (Zanthoxylum acanthopodium DC.) on seborrheic keratosis lesions. The study was conducted at the Outpatient Clinic of UPT Puskesmas Padang Bulan, Medan, Indonesia.
Ethical approval was obtained from the Health Research Ethics Committee of Universitas Sumatera Utara (Approval No. 66/KEPK/USU/2025), and authorization was granted by the Research Division of the North Sumatra Provincial Health Office. Written informed consent was obtained from all participants prior to enrollment.
Eligible participants were adults aged 18 to 50 years with clinically and dermoscopically diagnosed common seborrheic keratosis lesions located on the facial region. Participants applied a 1% andaliman fruit extract cream to the lesion area and were followed for 12 weeks. Lesion size was measured at baseline and during follow-up visits to assess treatment response.
Participants were excluded if they were pregnant or breastfeeding, had used topical treatments such as 5-fluorouracil, retinoids, chemical peeling, laser therapy, or systemic or topical antioxidants prior to enrollment. Participants were considered dropouts if they did not comply with treatment instructions, used additional therapies during the study period, or discontinued treatment before completion.
The primary outcome of the study was the change in lesion size over time, while secondary observations included safety and patient satisfaction with the treatment.
- Conditions
- Seborrheic Keratosis
- Being tested
- 1% Andaliman Fruit Extract Cream
- Keywords
- Andaliman, Zanthoxylum acanthopodium, Topical herbal therapy, Facial skin lesions, Benign skin tumor
- Medical subject headings
- Keratosis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Andaliman Fruit Extract CreamOther
Also called Zanthoxylum acanthopodium DC. Extract Cream
This intervention consisted of a topical cream containing 1% andaliman (Zanthoxylum acanthopodium DC.) fruit extract. Participants applied the cream directly to facial seborrheic keratosis lesions for a period of 12 weeks. The treatment was administered as a single intervention without a comparator, and participants were monitored for clinical response, safety, and adherence throughout the study period.
| Study group | Role | What they receive |
|---|---|---|
| Andaliman 1% Cream | Experimental | Participants in this single-arm study received topical treatment with 1% andaliman fruit extract cream (Zanthoxylum acanthopodium DC.). The cream was applied to facial seborrheic keratosis lesions for a treatment period of 12 weeks, with clinical evaluations performed at baseline and during follow-up visits. Receives: Other: 1% Andaliman Fruit Extract Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermoscopic Changes of Seborrheic Keratosis Lesions
Changes in dermoscopic features of seborrheic keratosis lesions before and after treatment with 1% andaliman fruit extract cream.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Jan 2025
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Seborrheic KeratosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study used a single-arm, one-group pretest-posttest design in which all participants received the same topical intervention and were evaluated before and after treatment.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sumatera Utara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sri Nauli Dewi Lubis, Universitas Sumatera Utara
- Investigators
- Imam Budi Putra, MD, Principal investigator, Prof. Dr. Chairuddin Panusunan Lubis Universitas Sumatera Utara Hospital, Medan, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334600
- Sponsor's protocol ID
- USU-DV-SK-AND-2025
- Other IDs
- No.66/KEPK/USU/2025
- Acronym
- ANDAL-SK
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adrian, Syahputra RA, Juwita NA, Astyka R, Lubis MF. Andaliman (Zanthoxylum acanthopodium DC.) a herbal medicine from North Sumatera, Indonesia: Phytochemical and pharmacological review. Heliyon. 2023 May 12;9(5):e16159. doi: 10.1016/j.heliyon.2023.e16159. eCollection 2023 May.
PubMed 37251868Sepriani O, Nirhamidah N, Handayani D. Potensi ekstrak andaliman (Zanthoxylum acanthopodium DC.) sebagai antibakteri. ALOTROP. 2020.
Chen L, Hu JY, Wang SQ. The role of antioxidants in photoprotection: a critical review. J Am Acad Dermatol. 2012 Nov;67(5):1013-24. doi: 10.1016/j.jaad.2012.02.009. Epub 2012 Mar 9.
PubMed 22406231James WD, Berger TG, Elston DM. Seborrheic keratosis. In: Andrews' Diseases of the Skin: Clinical Dermatology. 12th ed. Elsevier; 2016.
Hafner C, Hartmann A, van Oers JM, Stoehr R, Zwarthoff EC, Hofstaedter F, Landthaler M, Vogt T. FGFR3 mutations in seborrheic keratoses are already present in flat lesions and associated with age and localization. Mod Pathol. 2007 Aug;20(8):895-903. doi: 10.1038/modpathol.3800837. Epub 2007 Jun 22.
PubMed 17585316Rajan A, Shukla P, Pai V. Role of dermoscopy in diagnosing and differentiating seborrheic keratoses. Egyptian Journal of Dermatology and Venereology. 2022.
Klaassen KM. Treatment options for seborrheic keratosis. Dermatology Online Journal. 2018.
Schwartz RA. Seborrheic keratosis: Clinical features and management. Journal of Dermatological Treatment. 2020.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 1% Andaliman Fruit Extract Cream (Zanthoxylum Acanthopodium DC.) on Seborrheic Keratosis
- ClinicalTrials.gov ID
- NCT07334600
- Acronym / sponsor ID
- ANDAL-SK / USU-DV-SK-AND-2025
- Conditions
- Seborrheic Keratosis
- Keywords
- Andaliman, Zanthoxylum acanthopodium, Topical herbal therapy, Facial skin lesions, Benign skin tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas Sumatera UtaraUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 12 Jan 2026 (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.
Seborrheic keratosis is a common benign skin growth that often appears on the face and may cause cosmetic concerns. This study aimed to evaluate the effectiveness and safety of a 1% andaliman fruit extract cream (Zanthoxylum acanthopodium DC.) as a topical treatment for facial seborrheic keratosis.
The study used a one-group pretest-posttest design and involved adult patients with seborrheic keratosis who received the cream for 12 weeks. Changes in lesion size were measured over time, and participants were monitored for side effects and overall satisfaction. The results of this study are expected to provide evidence on the potential use of a natural topical therapy for improving the appearance of seborrheic keratosis.
Detailed description
This study was a quasi-experimental clinical trial using a one-group pretest-posttest design to evaluate the effect of a 1% andaliman fruit extract cream (Zanthoxylum acanthopodium DC.) on seborrheic keratosis lesions. The study was conducted at the Outpatient Clinic of UPT Puskesmas Padang Bulan, Medan, Indonesia.
Ethical approval was obtained from the Health Research Ethics Committee of Universitas Sumatera Utara (Approval No. 66/KEPK/USU/2025), and authorization was granted by the Research Division of the North Sumatra Provincial Health Office. Written informed consent was obtained from all participants prior to enrollment.
Eligible participants were adults aged 18 to 50 years with clinically and dermoscopically diagnosed common seborrheic keratosis lesions located on the facial region. Participants applied a 1% andaliman fruit extract cream to the lesion area and were followed for 12 weeks. Lesion size was measured at baseline and during follow-up visits to assess treatment response.
Participants were excluded if they were pregnant or breastfeeding, had used topical treatments such as 5-fluorouracil, retinoids, chemical peeling, laser therapy, or systemic or topical antioxidants prior to enrollment. Participants were considered dropouts if they did not comply with treatment instructions, used additional therapies during the study period, or discontinued treatment before completion.
The primary outcome of the study was the change in lesion size over time, while secondary observations included safety and patient satisfaction with the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study used a single-arm, one-group pretest-posttest design in which all participants received the same topical intervention and were evaluated before and after treatment.
| Arm | Type | Receives |
|---|---|---|
| Andaliman 1% Cream | Experimental | Other: 1% Andaliman Fruit Extract CreamParticipants in this single-arm study received topical treatment with 1% andaliman fruit extract cream (Zanthoxylum acanthopodium DC.). The cream was applied to facial seborrheic keratosis lesions for a treatment period of 12 weeks, with clinical evaluations performed at baseline and during follow-up visits. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 18-50 years.
- Patients diagnosed with common seborrheic keratosis lesions located on the facial region.
- Diagnosis confirmed by clinical and dermoscopic examination.
- Willing to participate in the study and provide written informed consent.
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women.
- Use of topical treatments such as 5-fluorouracil, tretinoin, adapalene, glycolic acid, alpha-hydroxy acid, or antioxidants prior to enrollment.
- History of chemical peeling or laser therapy before enrollment.
- Use of oral or injectable antioxidants before or during the study period.
- Non-compliance with study procedures or use of additional therapies during the study period.
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 |
|---|---|---|
| 1% Andaliman Fruit Extract CreamAlso: Zanthoxylum acanthopodium DC. Extract CreamThis intervention consisted of a topical cream containing 1% andaliman (Zanthoxylum acanthopodium DC.) fruit extract. Participants applied the cream directly to facial seborrheic keratosis lesions for a period of 12 weeks. The treatment was administered as a single intervention without a comparator, and participants were monitored for clinical response, safety, and adherence throughout the study period. | Other | Andaliman 1% Cream |
Primary outcome
Dermoscopic Changes of Seborrheic Keratosis Lesions
Time frame: Baseline and Week 12
Changes in dermoscopic features of seborrheic keratosis lesions before and after treatment with 1% andaliman fruit extract cream.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Background: PubMed 37251868Adrian, Syahputra RA, Juwita NA, Astyka R, Lubis MF. Andaliman (Zanthoxylum acanthopodium DC.) a herbal medicine from North Sumatera, Indonesia: Phytochemical and pharmacological review. Heliyon. 2023 May 12;9(5):e16159. doi: 10.1016/j.heliyon.2023.e16159. eCollection 2023 May.
- BackgroundSepriani O, Nirhamidah N, Handayani D. Potensi ekstrak andaliman (Zanthoxylum acanthopodium DC.) sebagai antibakteri. ALOTROP. 2020.
- Background: PubMed 22406231Chen L, Hu JY, Wang SQ. The role of antioxidants in photoprotection: a critical review. J Am Acad Dermatol. 2012 Nov;67(5):1013-24. doi: 10.1016/j.jaad.2012.02.009. Epub 2012 Mar 9.
- BackgroundJames WD, Berger TG, Elston DM. Seborrheic keratosis. In: Andrews' Diseases of the Skin: Clinical Dermatology. 12th ed. Elsevier; 2016.
- Background: PubMed 17585316Hafner C, Hartmann A, van Oers JM, Stoehr R, Zwarthoff EC, Hofstaedter F, Landthaler M, Vogt T. FGFR3 mutations in seborrheic keratoses are already present in flat lesions and associated with age and localization. Mod Pathol. 2007 Aug;20(8):895-903. doi: 10.1038/modpathol.3800837. Epub 2007 Jun 22.
- BackgroundRajan A, Shukla P, Pai V. Role of dermoscopy in diagnosing and differentiating seborrheic keratoses. Egyptian Journal of Dermatology and Venereology. 2022.
- BackgroundKlaassen KM. Treatment options for seborrheic keratosis. Dermatology Online Journal. 2018.
- BackgroundSchwartz RA. Seborrheic keratosis: Clinical features and management. Journal of Dermatological Treatment. 2020.
- General information about clinical trial registration and study protocol.Link provided by the sponsor.
- 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.
Imam Budi Putra, MD principal investigator
Prof. Dr. Chairuddin Panusunan Lubis Universitas Sumatera Utara Hospital, Medan, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1% Andaliman Fruit Extract Cream in people with Seborrheic Keratosis, run by Universitas Sumatera Utara 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 5 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: finished, as of the sponsor's last update on 12 Jan 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dermoscopic Changes of Seborrheic Keratosis Lesions (time frame: Baseline and Week 12). 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 NCT07334600, which also lists 8 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 12 Jan 2026.