Xanthelasma palpebrarum (XP) is the most common cutaneous form of xanthoma which is usually characterized by yellowish plaques over eyelids (1) and can be associated with dyslipidemia (2). Although XP is asymptomatic, treatment is often sought by patients owing to the cosmetic concerns.  

Despite availability of various treatment modalities for XP, treatment of XP still remains a daunting task for clinicians owing to lack of clinical response or recurrence. Several treatment modalities including surgical excision , topical use of acids like trichloroacetic acid (TCA), laser ablation, cryotherapy have been tried in XP, but there is no consensus in literature yet regarding the best treatment modality (3). 

Rationale

Surgical excision of XP is a safe and feasible minor surgical procedure requiring basic surgical skills and yielding excellent clinical and cosmetic outcome and minimal complication rate. TCA is one of the most commonly used modality by dermatologists in limited XP owing to the ease of application and availability. Different concentration of TCA has been used with 70% TCA being one of the most commonly used concentration.  Haque et al (4) and Nahas et al (5) evaluated 70 %TCA for XP for treatment of XP in their studies and found encouraging results.

Novelty

There are only few studies in literature comparing different modalities in management of XP leading to absence of consensus regarding the best treatment modality for XP.  Although there are few studies comparing various concentrations of TCA and energy-based devices in treatment of XP, to the best of our knowledge, there are no trials comparing the  safety and efficacy of surgical excision of XP and topical TCA application.

To fill this lacunae, we propose to compare the safety and efficacy of two of the most commonly used modalities TCA and surgical excision in management of XP in this split-face randomized trial.

Methodology

This  single blinded split face pilot randomized controlled trial  will  be  carried  out  in  the  department  of  dermatology and department of opthalmology,  in  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry. Thirty-six consecutive patients  presenting with bilateral XP (involving  at least one eyelid of both eyes) but  not involving more than one third of palapebral area involving any of the eyelids fulfilling the inclusion and exclusion criteria  and willing to participate in the study will  be  recruited  from  the  out-patient  clinic  of  the  department  of  dermatology and opthalmology.

This will be a split face study in which XP lesions involving the upper and/or lower eyelids of one eye of each patient will be randomized into one treatment group while XP involving the contralateral eye of the same patient will be randomized into another treatment group using computer-based randomization.

All the XP lesions involving the eyelids of one (right/left) eye irrespective of the total number of XP lesions and total number of eyelids (upper/lower/ or both)  involved will be referred as XP units (XPU) from hereon to avoid confusion.

This will be a split face study in which XPU of one eye of each patient will be randomized into one treatment group while XPU involving the contralteral eye of the same patient will be randomized into another treatment group using computer-based randomization with varying  block sizes of four or six with a ratio of 1: 1.

As this is a split face study , the first outcome in block randomization will imply XPU of left eye of the patient being randomized into group A and XPU of right eye being randomized into group B, while second outcome in block randomization will imply XPU of right eye of the patient being randomized into group A and XPU of left eye being randomized into group B. 

The  study  groups  will  include–

Group A:  XPU of one eye treated with surgical excision.

Group B- XPU of contralateral eye treated with TCA application.

All recruited patients will be subjected full detailed history and clinical examination. Baseline demographic and clinical details will be documented including the duration of the lesion, associated disorders and history of medications. Dermatological assessment of XPU in both groups will be done to assess the size, morphology, color, and other relevant details of the lesion. All the baseline demographic and clinical details will be entered in the pre-designed proforma (Annexure I) 

Group A: Surgical excision arm

For the XPU randomized into group A, complete surgical excision [ of all the XP lesions involving the eyelids of the one (right/eft) eye of the patient which has  been randomized to group A irrespective of the total number of  XP lesions or total number of eyelids (upper/lower/both) involved] will be performed under local anaesthesia and aseptic precautions.  Primary closure will be performed with 6-0 or 5-0 polypropylene sutures. Sutures will be removed on day 5-7.  The surgical excision of XPU if required will be repeated (in case of no/partial clinical response or recurrence) at week 4 and week 8 after first intervention, thus to a maximum of 3 sittings (weeks 0, 4 and 8)  overall or till complete clinical resolution (100 % reduction in size) , whichever is earlier.

Group B: TCA arm

For the XPU randomized into group B, topical TCA application [ of all the XP lesions involving the eyelids of the one (right/eft) eye of the patient which has  been randomized to group B irrespective of the total number of  XP lesions or total number of eyelids (upper/lower/both) involved] will be performed. The procedure will be performed with the patient in the supine position. Vaseline will be applied around the lesion to limit the area of application and tissue coagulation. The tip of a thin 6-mm toothpick will be dipped in 70% TCA will be applied topically on each XP lesion (group B XPU) without any excess drip by touching the sides of the bottle. The end point is frosting of the lesion.  The above procedure will be repeated (in case of  no /partial clinical response or recurrence) at week 4 and week 8 after first intervention, thus to a maximum of 3 sittings (weeks 0, 4 and 8) overall or till complete clinical resolution (100 % reduction in size), whichever is earlier.

Hyperlipidemia if present will be managed with diet, exercise and hypolipidemic drugs according to the guidelines in all the patients.

Study duration and follow up

The duration of study will be till 12 weeks from the day of first intervention in all the patients. The above procedures in their respective groups  will be repeated (in case of no/partial clinical response or recurrence) at week 4 and week 8 after first intervention, thus to a maximum of 3 sittings ( week 0, 4 and 8) overall or till complete clinical resolution (100 % reduction in size), whichever is earlier.

Patients will be followed up at weeks 4, 8 and 12 (week 0 being the day of first intervention). The visit at week 12 will be entirely for follow up and assessment of outcome parameters (response, adverse effects and other parameters) and no interventions will be performed. The site of intervention will be thoroughly assessed and recorded at each visit for outcome parameters and clinical photographs will be taken on each visit by blinded observer.