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Recruiting NCT07474883

Efficacy of 0.5% Topical Timolol Eye Drops in the Treatment of Post-Inflammatory Erythema Following Acne Vulgaris

Early Phase I Interventional Post Inflammtory Erythema Acne Vulgaris Erythema

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: Timolol 0.5% Ophthalmic Solution, Intense Pulsed Light.
Who it may be relevant to
Registry conditions: Post Inflammtory Erythema, Acne Vulgaris, Erythema. Basic parameters: from 12 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
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Efficacy of 0.5% Topical Timolol Eye Drops in the Treatment of Post-Inflammatory Erythema Following Acne Vulgaris: A Comparative Study With Intense Pulsed Light (IPL)

Overview

Post-inflammatory erythema (PIE) is a common sequela of acne vulgaris, characterized by persistent erythematous macules resulting from superficial vascular dilation. Current treatment options include energy-based devices such as intense pulsed light (IPL); however, these modalities may be costly and require specialized equipment. Timolol, a non-selective beta-adrenergic receptor blocker, has demonstrated vasoconstrictive properties and has been used off-label in dermatology for vascular-related conditions. This study aims to evaluate the efficacy and safety of topical 0.5% timolol ophthalmic solution in improving post-inflammatory erythema secondary to acne vulgaris and to compare its clinical outcomes with those achieved by intense pulsed light (IPL) therapy. This prospective comparative study will assess changes in erythema severity using standardized clinical evaluation and objective measurement tools over a defined treatment period. The findings may provide evidence for a cost-effective and accessible therapeutic alternative for managing post-acne erythema.

Interventions

  • Drug Timolol 0.5% Ophthalmic Solution
    Participants will apply topical timolol 0.5% ophthalmic solution to affected areas twice daily for 4 weeks. The medication will be gently applied to post-inflammatory erythematous lesions following acne vulgaris. Clinical response will be assessed at baseline and scheduled follow-up visits.
  • Device Intense Pulsed Light
    Participants will receive Intense Pulsed Light (IPL) therapy targeting post-inflammatory erythema lesions. Treatment will be performed once at the beginning, according to standard dermatologic protocols. Clinical improvement will be evaluated at each follow-up visit.

Primary outcome measures

  • Change in Post-Inflammatory Erythema Severity Score measured by Clinician Erythema Assessment (CEA) Scale 0-4 [Time frame: Baseline, Day 14 and Day 28]
  • Number of Post Inflammatory Erythema lesions [Time frame: Baseline, Day 14 and Day 28]
Secondary outcome measures (3)
  • Number of participants with local adverse events [Time frame: Baseline to Day 28]
  • Number of participants with systemic adverse events [Time frame: Baseline to Day 28]
  • Patient aesthetic satisfaction score measured by Visual Analog Scale (VAS) [Time frame: Day 28]

Eligibility criteria

Inclusion Criteria: Participants must meet all of the following criteria:

  • Age ≥ 12 years with a history of acne vulgaris.
  • Clinically diagnosed with post-inflammatory erythema (PIE) secondary to acne vulgaris.
  • Willing and able to provide informed consent (or assent with parental/guardian consent if under 18 years of age).

Exclusion criteria

  • Refusal to participate or inability to comply with study procedures (examinations, treatment, follow-up visits), or loss to follow-up.
  • Presence of post-inflammatory hyperpigmentation (PIH) at the study site that may interfere with accurate assessment of erythema.
  • Presence of other dermatologic conditions affecting the treatment area (e.g., atopic dermatitis, rosacea, lupus erythematosus).
  • Known hypersensitivity or adverse reaction to timolol or other beta-adrenergic receptor blockers.
  • Pregnant or breastfeeding women.
  • History of cardiovascular or respiratory conditions contraindicating beta-blocker use (e.g., asthma, atrioventricular block, bradycardia <50 beats per minute, hypotension).
  • Use of other topical medications or cosmetic products (except sunscreen) on the study area during the study period.

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
Single blind
Primary purpose
Other

Study locations

Vietnam · 1 center
  • Ho Chi Minh City Hospital of Dermato-Venereology — Ho Chi Minh City

Identifiers

NCT: NCT07474883 · 447/CN-BVDL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗