NCT07721779

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2026

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
Last Updated

July 23, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

July 13, 2026

Last Update Submit

July 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Size of chalazian

    measured using the slit lamp

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

Study Arms (2)

Steam mask

EXPERIMENTAL

A steam mask is being used to treat chalazion in paediatric patients; comparing its effectiveness to warm compresses.

Device: Steam device

Warm compress

EXPERIMENTAL

A warm compress is being used as the first-line conservative treatment if chalazion, with the aim to compare its effectiveness with a steam mask.

Other: Warm Compress

Interventions

The steam mask is made up of a fabric mask with 2 detachable steam eye cups (fabric) that contain self-hydrating beads.

Steam mask

A warm compress consists of a small towel / flannel that is soak in cooled boiled water and placed over the chalazion.

Warm compress

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospitals of Sheffield Trust

Sheffield, United Kingdom

RECRUITING

MeSH Terms

Conditions

Chalazion

Condition Hierarchy (Ancestors)

CystsNeoplasmsEyelid DiseasesEye Diseases

Study Officials

  • Viral Sheth, Phd

    University of Sheffield

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Gosling, Mmedsci ACP

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2026

First Posted

July 23, 2026

Study Start

March 10, 2026

Primary Completion

July 15, 2026

Study Completion

July 15, 2026

Last Updated

July 23, 2026

Record last verified: 2026-06

Locations