Clinical trial NCT06839638: Efficacy of 100% Trichloroacetic Acid Vs. Cryotherapy in Xanthelasma Palpebrarum
Official title: Efficacy of Trichloroacetic Acid (100%) Versus Cryotherapy in Patients with Xanthelasma Palpebrarum
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Xanthelasma Palpebrarum
Keywords: Hyperlipidemia-related Skin Lesions
Non-Surgical Treatment for Xanthelasma
Chemical Cauterization
Lead sponsor: Nishtar Medical University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Efficacy of 100% Trichloroacetic Acid (TCA) versus Cryotherapy in Xanthelasma Palpebrarum
timeFrame: Six weeks after treatment initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Nishtar Hospital, Multan
state: Punjab
Study officials:
affiliation: Nishtar Hospital, Multan
name: Muhammad Irfan Jamil
role: PRINCIPAL_INVESTIGATOR
References: