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

NCT07334600 | Completed

• 2 other identifiers: USU-DV-SK-AND-2025No.66/KEPK/USU/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Seborrheic Keratosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Dermoscopic Changes of Seborrheic Keratosis Lesions

  Changes in dermoscopic features of seborrheic keratosis lesions before and after treatment with 1% andaliman fruit extract cream.

  Baseline and Week 12

Study Arms (1)

Andaliman 1% Cream

EXPERIMENTAL

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

Interventions

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.

Also known as: Zanthoxylum acanthopodium DC. Extract Cream

Andaliman 1% Cream

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Sumatera Utara: lead

Study Sites (1)

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

Medan, North Sumatra, 20154, Indonesia

Location

Related Publications (8)

• 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.

  PMID: 37251868 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 22406231 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 17585316 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

Related Links

• General information about clinical trial registration and study protocol.

MeSH Terms

Conditions

Keratosis, Seborrheic

Condition Hierarchy (Ancestors)

Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Imam Budi Putra, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Departement of Dermatology and Venereology, Faculty of Medicine, Universitas Sumatera Utara, Medan, Indonesia

Model Details: 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.

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: January 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)