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

NCT07474883 | Recruiting Early Phase 1

• 1 other identifier: 447/CN-BVDL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Erythema; Post Inflammtory Erythema; Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Number of participants with local adverse events

  Baseline to Day 28

• Number of participants with systemic adverse events

  Baseline to Day 28

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

  Day 28

Study Arms (2)

Topical Timolol 0.5%

EXPERIMENTAL

Drug: Timolol 0.5% Ophthalmic Solution

Intense Pulsed Light (IPL)

ACTIVE COMPARATOR

Device: Intense Pulsed Light

Interventions

Intense Pulsed Light DEVICE

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.

Intense Pulsed Light (IPL)

Timolol 0.5% Ophthalmic Solution DRUG

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.

Topical Timolol 0.5%

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pham Ngoc Thach University of Medicine: lead

Study Sites (1)

Ho Chi Minh City Hospital of Dermato-Venereology

Ho Chi Minh City, Vietnam

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris; Erythema

Interventions

Timolol; Ophthalmic Solutions; Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Phototherapy; Therapeutics

Central Study Contacts

Pham Duc Vu

CONTACT

+84 913681158; vupham14@pnt.edu.vn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 16, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): August 9, 2026
• Study Completion (Estimated): October 9, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

VN (1)