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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Timolol 0.5% | Experimental |
| |
| Intense Pulsed Light (IPL) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria: Participants must meet all of the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pham Duc Vu | Contact | +84 913681158 | vupham14@pnt.edu.vn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ho Chi Minh City Hospital of Dermato-Venereology | Recruiting | Ho Chi Minh City | Vietnam |
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|
| 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. |
|
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 |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| D004890 | Erythema |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013999 | Timolol |
| D009883 | Ophthalmic Solutions |
| D062325 | Intense Pulsed Light Therapy |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D010789 | Phototherapy |
| D013812 | Therapeutics |
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