Efficacy of 100% Trichloroacetic Acid Vs. Cryotherapy in Xanthelasma Palpebrarum

NCT06839638 | Active Not Recruiting

• 1 other identifier: NishtarMU2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Xanthelasma palpebrarum (XP) is a common skin condition characterized by yellowish plaques that typically develop around the eyelids. While not harmful, these plaques can be a cosmetic concern for many individuals. Several treatment options exist, but there is no clear consensus on the most effective method. This study aims to compare the effectiveness of two treatment options-100% trichloroacetic acid (TCA) and cryotherapy-in removing xanthelasma palpebrarum. Trichloroacetic acid is a chemical solution that removes the lesions by controlled cauterization, while cryotherapy involves freezing the plaques using liquid nitrogen. A total of 60 patients with xanthelasma will be randomly assigned to receive either 100% TCA or cryotherapy. The success of the treatment will be determined based on whether the plaques flatten and disappear within six weeks. The results of this study will help identify the more effective treatment method, which can be used to improve patient outcomes and minimize recurrence. The study is being conducted at Nishtar Hospital Multan and aims to provide valuable insights for dermatologists in choosing the best treatment for xanthelasma palpebrarum.

Conditions

Xanthelasma Palpebrarum

Keywords

Hyperlipidemia-related Skin Lesions; Non-Surgical Treatment for Xanthelasma; Chemical Cauterization

Outcome Measures

Primary Outcomes (1)

• Efficacy of 100% Trichloroacetic Acid (TCA) versus Cryotherapy in Xanthelasma Palpebrarum

  Complete disappearance and flattening of xanthelasma plaques, assessed through clinical examination by a blinded dermatologist.

  Six weeks after treatment initiation

Study Arms (2)

Group TCA

EXPERIMENTAL

will receive 100% TCA application to xanthelasma lesions using the dipstick method.

Procedure: 100% Trichloroacetic Acid (TCA)

Group Cryotherapy

ACTIVE COMPARATOR

will receive cryotherapy using liquid nitrogen. A single freeze-thaw cycle will be performed until a narrow halo of white ice forms around the lesion.

Procedure: Cryotherapy (Liquid Nitrogen)

Interventions

100% Trichloroacetic Acid (TCA) PROCEDURE

Patients in this group will receive 100% TCA application to xanthelasma lesions using the dipstick method. The surrounding skin will be protected with white soft paraffin to prevent chemical spillage. Post-treatment, Fusidic acid 2% will be applied twice daily for one week. Treatment efficacy will be assessed after six weeks.

Group TCA

Cryotherapy (Liquid Nitrogen) PROCEDURE

Patients in this group will receive cryotherapy using liquid nitrogen. A single freeze-thaw cycle will be performed until a narrow halo of white ice forms around the lesion. Post-treatment care will include Fusidic acid 2% applied twice daily for one week. Treatment efficacy will be assessed after six weeks.

Group Cryotherapy

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 20-55 years
• Either male or female
• No prior treatment for xanthelasma palpebrarum (XP)
• Patients on anti-lipidemic drugs for systemic control of disease
• Bilateral xanthelasmas measuring between 0.5 cm to 3 cm

You may not qualify if:

• History of hypersensitivity to TCA or cryotherapy.

Sponsors & Collaborators

• Nishtar Medical University: lead

Study Sites (1)

Nishtar Hospital, Multan

Multan, Punjab Province, 66000, Pakistan

Location

MeSH Terms

Conditions

Xanthomatosis

Interventions

Trichloroacetic Acid; Cryotherapy

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Chloroacetates; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated; Hydrocarbons; Therapeutics

Study Officials

• Muhammad Irfan Jamil

  Nishtar Hospital, Multan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 21, 2025
• Study Start: September 7, 2024
• Primary Completion: April 7, 2025
• Study Completion: April 7, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)