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

Early Phase 1RecruitingNCT07474883

Pham Ngoc Thach University of Medicine60 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Post Inflammtory Erythema Acne Vulgaris Erythema

Interventions

Timolol 0.5% Ophthalmic SolutionDRUG

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.

Intense Pulsed LightDEVICE

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.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Post-Inflammatory Erythema Severity Score measured by Clinician Erythema Assessment (CEA) Scale 0-4

Post-inflammatory erythema severity will be assessed using the Clinician Erythema Assessment (CEA) scale ranging from 0 (clear) to 4 (severe erythema). Higher scores indicate more severe erythema.

Time frame: Baseline, Day 14 and Day 28

Number of Post Inflammatory Erythema lesions

The number of facial post-inflammatory erythema lesions will be counted by a dermatologist during clinical examination.

Time frame: Baseline, Day 14 and Day 28

Secondary Outcomes

Number of participants with local adverse events

Local adverse events related to the treatment (such as skin irritation, burning sensation, dryness, erythema worsening, or edema) will be recorded during the study period.

Time frame: Baseline to Day 28

Number of participants with systemic adverse events

Systemic adverse events potentially related to treatment (such as dizziness, hypotension, bradycardia, or other systemic symptoms) will be monitored and recorded during the study period.

Time frame: Baseline to Day 28

Patient aesthetic satisfaction score measured by Visual Analog Scale (VAS)

Patient aesthetic satisfaction with the treatment outcome will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates the worst aesthetic appearance and 10 indicates the best aesthetic appearance. Higher scores indicate greater patient satisfaction with the skin appearance.

Time frame: Day 28