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

Universitas Sumatera Utara

Status: Completed

Conditions: Seborrheic Keratosis

Treatments: Other: 1% Andaliman Fruit Extract Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT07334600

USU-DV-SK-AND-2025

No.66/KEPK/USU/2025 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Andaliman 1% Cream

Experimental group

Description:

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.

Treatment:

Other: 1% Andaliman Fruit Extract Cream