An Early Phase 1 interventional study of Timolol 0.5% Ophthalmic Solution and Intense Pulsed Light in Post Inflammtory Erythema, Acne Vulgaris and Erythema, sponsored by Pham Ngoc Thach University of Medicine. Recruiting at 1 site in Vietnam. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Pham Ngoc Thach University of Medicine · Early Phase 1, Interventional, and Other
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.
790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 672 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Pham Ngoc Thach University of Medicine is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
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Inclusion Criteria: Participants must meet all of the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Timolol 0.5% Ophthalmic Solution
Device: Intense Pulsed Light
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.
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.
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
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
Plan to share: Undecided
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Studies of the drug tested here: Timolol
Pham Ngoc Thach University of Medicine