Post Inflammtory Erythema, Acne Vulgaris, Erythema
Conditions
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.
Interventions
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.
DEVICEIntense 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.
Sponsors
Pham Ngoc Thach University of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Post-Inflammatory Erythema Severity Score measured by Clinician Erythema Assessment (CEA) Scale 0-4 | 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. |
| Number of Post Inflammatory Erythema lesions | Baseline, Day 14 and Day 28 | The number of facial post-inflammatory erythema lesions will be counted by a dermatologist during clinical examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with local adverse events | 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. |
| Number of participants with systemic adverse events | 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. |
| Patient aesthetic satisfaction score measured by Visual Analog Scale (VAS) | 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. |
Countries
Vietnam
Contacts
CONTACTPham Duc Vu
Outcome results
None listed