Effect of 1% Andaliman Fruit Extract Cream on Facial Seborrheic Keratosis (ANDAL-SK)

December 30, 2025 updated by: Sri Nauli Dewi Lubis, Universitas Sumatera Utara

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • North Sumatra
      • Medan, North Sumatra, Indonesia, 20154
        • Outpatient Clinic, Prof. Dr. Chairuddin Panusunan Lubis Universitas Sumatera Utara Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Andaliman 1% Cream
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.
Other: 1% Andaliman Fruit 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.
Other Names:
  • Zanthoxylum acanthopodium DC. Extract Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Sumatera Utara

Investigators

  • Principal Investigator: Imam Budi Putra, MD, Prof. Dr. Chairuddin Panusunan Lubis Universitas Sumatera Utara Hospital, Medan, Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

April 1, 2025

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USU-DV-SK-AND-2025
  • No.66/KEPK/USU/2025 (Other Identifier: Health Research Ethics Committee, Faculty of Medicine, Universitas Sumatera Utara)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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