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

NCT ID: NCT06839638

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-07
• Study Completion Date: 2025-04-07

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.

Detailed Description

Xanthelasma palpebrarum (XP) is a common dermatological condition characterized by the presence of yellowish plaques around the inner canthus of the eyelids. While benign, these plaques are often a significant cosmetic concern for patients. Various treatment modalities are available, including surgical excision, laser therapy, electrocauterization, chemical cauterization with trichloroacetic acid (TCA), and cryotherapy. However, each treatment option has its limitations, including variable efficacy, risk of recurrence, and potential side effects. Despite the availability of multiple therapeutic approaches, no consensus exists regarding the most effective and cosmetically acceptable treatment for XP.

This randomized controlled trial aims to compare the efficacy of 100% trichloroacetic acid (TCA) versus cryotherapy (liquid nitrogen) for the treatment of xanthelasma palpebrarum. TCA is a commonly used chemical cauterizing agent that causes epidermal necrosis, leading to the sloughing of lipid-laden histiocytes responsible for XP formation. Cryotherapy, on the other hand, involves the application of extreme cold to induce tissue destruction, promoting lesion resolution. Both modalities are non-surgical, cost-effective, and relatively simple to perform, making them viable options for outpatient dermatological treatment.

Sixty patients with xanthelasma palpebrarum will be enrolled in the study and randomly allocated into two treatment groups. Group A will receive 100% TCA application using the dipstick method, ensuring controlled application while protecting the surrounding skin with white soft paraffin. Group B will be treated with cryotherapy, using a single freeze-thaw cycle with liquid nitrogen until a narrow halo of white ice forms around the lesion. Following the procedure, all patients will apply Fusidic acid 2% twice daily for one week as post-treatment care.

The primary outcome measure will be the complete resolution of xanthelasma, assessed at six weeks after treatment through clinical examination and photographic documentation. The study will also evaluate secondary outcomes, including post-treatment adverse effects such as hypopigmentation, erythema, ulceration, and scarring. A blinded consultant dermatologist will assess treatment response and determine efficacy based on predefined criteria.

This study is particularly significant as there is currently no published comparative study from South Punjab evaluating these two treatment modalities. By providing evidence on the relative efficacy and safety of TCA and cryotherapy, this research will help dermatologists select the most effective, safe, and cosmetically acceptable treatment for XP. The findings may also contribute to future treatment guidelines, improving patient outcomes and reducing the need for retreatment in clinical practice.

Conditions

Xanthelasma Palpebrarum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group TCA

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

Group Type: EXPERIMENTAL

100% Trichloroacetic Acid (TCA)

Intervention Type: 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 Cryotherapy

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.

Group Type: ACTIVE_COMPARATOR

Cryotherapy (Liquid Nitrogen)

Intervention Type: 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.

Interventions

100% Trichloroacetic Acid (TCA)

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.

Intervention Type: PROCEDURE

Cryotherapy (Liquid Nitrogen)

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• History of hypersensitivity to TCA or cryotherapy.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nishtar Medical University

OTHER

Sponsor Role: lead

Responsible Party

Amra Batool

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammad Irfan Jamil

Role: PRINCIPAL_INVESTIGATOR

Nishtar Hospital, Multan

Locations

Nishtar Hospital, Multan

Multan, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

NishtarMU2

Identifier Type: -

Identifier Source: org_study_id