About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Timolol 0.5% Ophthalmic Solution
DrugParticipants 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
DeviceParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Number of Post Inflammatory Erythema lesions
The number of facial post-inflammatory erythema lesions will be counted by a dermatologist during clinical examination.
Secondary outcomes
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.
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.
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.
Sponsors and contacts
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