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

NCT ID: NCT07334600

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-04-01

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.

Conditions

Seborrheic Keratosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

1% Andaliman Fruit Extract Cream

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Zanthoxylum acanthopodium DC. Extract Cream

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitas Sumatera Utara

OTHER

Sponsor Role: lead

Responsible Party

Sri Nauli Dewi Lubis

Departement of Dermatology and Venereology, Faculty of Medicine, Universitas Sumatera Utara, Medan, Indonesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Imam Budi Putra, MD

Role: PRINCIPAL_INVESTIGATOR

Prof. Dr. Chairuddin Panusunan Lubis Universitas Sumatera Utara Hospital, Medan, Indonesia

Locations

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

Medan, North Sumatra, Indonesia

Countries

Indonesia

References

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.

Reference Type: BACKGROUND

PMID: 22406231 (View on PubMed)

James WD, Berger TG, Elston DM. Seborrheic keratosis. In: Andrews' Diseases of the Skin: Clinical Dermatology. 12th ed. Elsevier; 2016.

Reference Type: BACKGROUND

Sepriani O, Nirhamidah N, Handayani D. Potensi ekstrak andaliman (Zanthoxylum acanthopodium DC.) sebagai antibakteri. ALOTROP. 2020.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 37251868 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17585316 (View on PubMed)

Rajan A, Shukla P, Pai V. Role of dermoscopy in diagnosing and differentiating seborrheic keratoses. Egyptian Journal of Dermatology and Venereology. 2022.

Reference Type: BACKGROUND

Klaassen KM. Treatment options for seborrheic keratosis. Dermatology Online Journal. 2018.

Reference Type: BACKGROUND

Schwartz RA. Seborrheic keratosis: Clinical features and management. Journal of Dermatological Treatment. 2020.

Reference Type: BACKGROUND

Related Links

https://clinicaltrials.gov

General information about clinical trial registration and study protocol.

Other Identifiers

No.66/KEPK/USU/2025

Identifier Type: OTHER

Identifier Source: secondary_id

USU-DV-SK-AND-2025

Identifier Type: -

Identifier Source: org_study_id