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Completed

NCT Number: NCT07334600

Effect of 1% Andaliman Fruit Extract Cream on Facial 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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinic, Prof. Dr. Chairuddin Panusunan Lubis Universitas Sumatera Utara Hospital

Medan, North Sumatra, 20154, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1% Andaliman Fruit Extract Cream

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universitas Sumatera Utara

Other

Registry information

Official study title

The Effect of 1% Andaliman Fruit Extract Cream (Zanthoxylum Acanthopodium DC.) on Seborrheic Keratosis

Acronym: ANDAL-SK

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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