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Not yet recruiting NCT07405138

Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion

No phase Interventional Chalazion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sham IPL, Active IPL.
Who it may be relevant to
Registry conditions: Chalazion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

To study the effectiveness and safety of IPL treatment for Chalazion

Detailed description

The study aims to evaluate the effectiveness and safety of IPL therapy for the treatment of chalazion. The effect of IPL on chalazion will be examined in a masked randomized controlled study. Subjects in the study arm will be treated with IPL, while subjects in the control arm will be treated with sham IPL. A significant difference in the outcomes of the two arms will provide support for a genuine contribution of the IPL treatment

Interventions

  • Device Sham IPL
    Three sham IPL treatments in 1-week interval followed by 1 follow-up 4 weeks after the last treatment
  • Device Active IPL
    Three active IPL treatments in 1-week interval followed by 1 follow-up 4 weeks after the last treatment

Primary outcome measures

  • The percentage of resolved chalazion 4 weeks after the last treatment in the study group and the control group [Time frame: 4 weeks after the last treatment]
Secondary outcome measures (2)
  • Percentage change from baseline in lesion size in both groups [Time frame: 4 weeks after the last treatment]
  • Time to resolution which is defined as a reduction of at least 80% in lesion size in both groups [Time frame: 4 weeks after last treatment]

Eligibility criteria

Inclusion criteria

  • Subject is able to read, understand, and sign an Informed Consent Form (ICF)
  • 18 years of age or older
  • Clinical diagnosis of chalazion in the inflammatory stage
  • Subject is willing to comply with all study procedures-

Exclusion criteria

  • Concurrent eyelid infection
  • Chalazion with atypical features, which to the opinion of the study investigator is inadequate for a study
  • Recurring Chalazion
  • Floppy eyelid syndrome
  • Demodex blepharitis patients taking Lotilaner ophthalmic solution within 30 days prior to screening
  • Ocular surgery within 3 months prior to screening
  • Current diagnosis of malignant tumors in the affected eyelid, including:

sebaceous carcinoma and basal cell carcinoma

  • Laser Assisted In Situ Keratomileusis (LASIK)/Small Incision Lenticule Extraction (SMILE) surgery, within 1 year prior to screening
  • Radial Keratotomy (RK) surgery
  • Recent ocular trauma, within 3 months prior to screening
  • Pre-cancerous lesions or skin cancer in the planned treatment area
  • Severe active allergies, or other severe uncontrolled eye disorders affecting the ocular surface
  • Uncontrolled infections or uncontrolled immunosuppressive diseases
  • Best corrected visual acuity worse than 20/200 in either eye
  • Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., prior chemical burn, Epithelial Basement Membrane Dystrophy - EBMD)
  • Within 1 week prior to screening, use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, including: Isotretinoin, Tetracycline, Doxycycline, and St. John's Wort
  • Active sun burn in the treatment area
  • Anterior chamber inflammation
  • Corneal edema
  • Any condition revealed w

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Manhattan Face and Eye clinic — New York
  • Periman Eye Institute — Seattle

Identifiers

NCT: NCT07405138 · LUM-VBU-IPL-26-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗