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Clinical Trials/NCT07721779
NCT07721779RecruitingNot Applicable

Is the Use of a Steam Mask an Effective Treatment for Paediatric Chalazion in Comparison to Traditional Warm Compresses?

University of Sheffield1 site in 1 country28 target enrollmentStarted: March 10, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
28
Locations
1
Primary Endpoint
Size of chalazian

Study Overview

Brief Summary

Is the use of a steam mask an effective treatment for paediatric chalazion in comparison to traditional warm compresses?

This study will aim to assess the difference between these two methods.

Detailed Description

Protocol

Is the use of a steam mask an effective treatment for paediatric chalazion in comparison to traditional warm compresses?

Background

Chalazia are chronic sterile lipogranulomas of the meibomian or Zeis glands that can be refractory in nature due to retained sebaceous secretions. Histopathology of chalazia identifies a chronic inflammatory picture, with extracellular fat deposits surrounded by lipid-laden epithelioid cells, multinucleated giant cells and lymphocytes. The condition can often be associated with diagnoses, such as blepharitis, meibomian gland dysfunction and dry eye disease. Chalazia will often present as a gradual, painless and round lesion on the either the upper or lower eyelid. It is expected to be non-tender (unless associated with acute inflammation due to infection), non-fluctuant and non-erythematous, and can either present as a single lesion (chalazion) or as multiple lesions (chalazia). Symptoms can present as reduced vision, epiphora, irritation and cosmetic concerns. For paediatric chalazion, an incidence of 2% has been found, which would account for approximately 288,071 of the UK population aged under the age of 18 years, according to population statistics.

The condition is known to be benign and self-limiting in nature, but time until resolution can vary, and therefore treatment is often sought. Management of chalazia usually begins with warm compresses, eyelid massage and eyelid hygiene, unless the patient presentation dictates a more medicalised approach, for example, in cases of cellulitis. Warm compresses provide heat to the chalazion in order to melt the meibum obstructing the meibomian gland. The average melting temperature of meibum is approximately 32oC, increasing to approximately 35oC when there is an obstruction or altered secretions, and therefore it is recommended to achieve a heat of 40oC for therapeutic treatment. A secondary benefit of a heat source in the form of a warm compress is due to activation of the heat shock response and subsequent expression of localised heat shock proteins (HSP). HSPs maintain cellular protein homeostasis (proteostasis) by acting as molecular chaperones and assisting in folding of polypeptides, and other cellular activity, ensuring the normal functioning of cells. Therefore, once activated, the HSPs will assist in functions such as degradation of misfolded proteins and apoptosis regulation, both important functions for cells/tissue damaged by inflammation. HSPs have also been found to inhibit the transcription of genes encoding pro-inflammatory cytokines. Histopathological analysis of chalazion shows the presence of inflammatory cells, and therefore the presence of a heat source may help inhibit the inflammatory response of the chalazion and promote normal functioning of cells. In experimental disease models, HSPs have been shown to prevent or arrest inflammatory damage for patients with chronic inflammatory diseases. As a chalazion is a chronic inflammatory condition, activation of HSPs at the site of the heat source may reduce the inflammatory component of the condition.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
5 Years to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosed chalazion (isolated or multiple).
  • Aged between 5 - <16 years (reading age for participant information leaflets).
  • A minimum head circumference of 50cm.
  • Access to a microwave with a rotating plate.

Exclusion Criteria

  • Current or previous treatment including: triamcinolone acetonide injection and, incision and curettage.
  • Current treatment including: oral or topical antibiotics and/or topical steroids.
  • Other ocular co-morbidities (excluding blepharitis, meibomian gland dysfunction, and dry eye disease).
  • Dermatological diagnoses that contraindicate the use of heat on the face.
  • Suspicious lesion with abnormal surrounding tissue that requires further investigation.

Outcomes

Primary Outcomes

Size of chalazian

Time Frame: From enrollment (first visit) to the end of the treatment at 8 weeks.

measured using the slit lamp

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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