Post Inflammtory ErythemaEarly Phase 1NCT07474883
Efficacy of 0.5% Topical Timolol Eye Drops in the Treatment of Post-Inflammatory Erythema Following Acne Vulgaris
A Early Phase 1 study testing Timolol 0.5% Ophthalmic Solution and Intense Pulsed Light in people with Post Inflammtory Erythema and Acne Vulgaris, run by Pham Ngoc Thach University of Medicine at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Post Inflammtory Erythema, Acne Vulgaris, Erythema
- What is being tested?
- Timolol 0.5% Ophthalmic Solution and Intense Pulsed Light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 9 Mar 2026to 9 Oct 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Ho Chi Minh City Hospital of Dermato-Venereology
Ho Chi Minh City
About this study
Official 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)
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.
- Conditions
- Post Inflammtory Erythema, Acne Vulgaris, Erythema
- Being tested
- Timolol 0.5% Ophthalmic Solution, Intense Pulsed Light
- Medical subject headings
- Acne Vulgaris, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timolol 0.5% Ophthalmic SolutionDrug
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 LightDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Topical Timolol 0.5% | Experimental | Not described Receives: Drug: Timolol 0.5% Ophthalmic Solution |
| Intense Pulsed Light (IPL) | Active comparator | Not described Receives: Device: Intense Pulsed Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Day 14 and Day 28
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start9 Mar 2026 (estimated)
- Primary completion9 Aug 2026 (estimated)
- Study completion9 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Inflammtory ErythemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pham Ngoc Thach University of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474883
- Sponsor's protocol ID
- 447/CN-BVDL
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07474883
- Acronym / sponsor ID
- 447/CN-BVDL
- Conditions
- Post Inflammtory Erythema, Acne Vulgaris, Erythema
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pham Ngoc Thach University of MedicineUniversity, hospital or other
- Study start
- 9 Mar 2026 (estimated)
- Primary completion
- 9 Aug 2026 (estimated)
- Study completion
- 9 Oct 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Timolol 0.5% | Experimental | Drug: Timolol 0.5% Ophthalmic Solution |
| Intense Pulsed Light (IPL) | Active comparator | Device: Intense Pulsed Light |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timolol 0.5% Ophthalmic SolutionParticipants 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. | Drug | Topical Timolol 0.5% |
| Intense Pulsed LightParticipants 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. | Device | Intense Pulsed Light (IPL) |
Primary outcome
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.
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.
3 secondary outcomes
Number of participants with local adverse events
Time frame: Baseline to Day 28
Number of participants with systemic adverse events
Time frame: Baseline to Day 28
Patient aesthetic satisfaction score measured by Visual Analog Scale (VAS)
Time frame: Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Timolol 0.5% Ophthalmic Solution and Intense Pulsed Light in people with Post Inflammtory Erythema and Acne Vulgaris, run by Pham Ngoc Thach University of Medicine at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pham Duc Vu (+84 913681158, vupham14@pnt.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Post-Inflammatory Erythema Severity Score measured by Clinician Erythema Assessment (CEA) Scale 0-4 (time frame: Baseline, Day 14 and Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.