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

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)

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 Overview

• Status: Recruiting
• Conditions: Erythema; Acne Vulgaris; Post Inflammtory Erythema
• Intervention / Treatment: Drug: Timolol 0.5% Ophthalmic Solution; Device: Intense Pulsed Light

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Pham Duc Vu; Phone Number: +84 913681158; Email: vupham14@pnt.edu.vn

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam
    • Recruiting
    • Ho Chi Minh City Hospital of Dermato-Venereology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical Timolol 0.5%	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.
Active Comparator: Intense Pulsed Light (IPL)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, Day 14 and Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Day 28

Collaborators and Investigators

• Sponsor: Pham Ngoc Thach University of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): March 9, 2026
• Primary Completion (Estimated): August 9, 2026
• Study Completion (Estimated): October 9, 2026

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations; Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Acne Vulgaris; Erythema; Pharmaceutical Solutions; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Therapeutics; Thiazoles; Azoles; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Amines; Solutions; Specialty Uses of Chemicals; Alcohols; Propanolamines; Amino Alcohols; Propanols; Thiadiazoles; Morpholines; Oxazines; Phototherapy; Ophthalmic Solutions; Timolol; Intense Pulsed Light Therapy
• Other Study ID Numbers: 447/CN-BVDL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No