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Effect of 1% Andaliman Fruit Extract Cream on Facial Seborrheic Keratosis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07334600
Acronym
ANDAL-SK
Enrollment
40
Registered
2026-01-12
Start date
2025-01-01
Completion date
2025-04-01
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seborrheic Keratosis

Keywords

Andaliman, Zanthoxylum acanthopodium, Topical herbal therapy, Facial skin lesions, Benign skin tumor

Brief 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. 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.

Interventions

OTHER1% 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.

Sponsors

Universitas Sumatera Utara
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Dermoscopic Changes of Seborrheic Keratosis LesionsBaseline and Week 12Changes in dermoscopic features of seborrheic keratosis lesions before and after treatment with 1% andaliman fruit extract cream.

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026