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NCT Number: NCT07474883

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

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.

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Key information

Conditions

Post Inflammtory Erythema Acne Vulgaris Acneiform Eruptions Erythema Pathological Conditions, Signs and Symptoms Sebaceous Gland Diseases Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ho Chi Minh City Hospital of Dermato-Venereology

Ho Chi Minh City, Vietnam

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Baseline, Day 14 and Day 28

    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.

  2. Number of Post Inflammatory Erythema lesions

    Time frame: Baseline, Day 14 and Day 28

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

Secondary outcomes

  1. Number of participants with local adverse events

    Time frame: Baseline to Day 28

    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.

  2. Number of participants with systemic adverse events

    Time frame: Baseline to Day 28

    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.

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

    Time frame: Day 28

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pham Duc Vu

CONTACT

[email protected]

+84 913681158

Sponsors and collaborators

Lead sponsor

Pham Ngoc Thach University of Medicine

Other

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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