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A randomized, double blinded, split-face study of efficacy and safety of topical 0.05% Oxymetazoline on post acne erythema

A randomized, double blinded, split-face study of efficacy and safety of topical 0.05% Oxymetazoline on post acne erythema

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20211207004
Enrollment
30
Registered
2021-12-07
Start date
2021-12-14
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with mild to severe post acne erythema according to Clinician erythema assessment criteria Post acne erythema, Oxymetazoline hydrochloride

Interventions

According to the randomization, subjects will be instructed to apply a maximum of 10 drops of topical 0.05% Oxymetazoline hydrochloride on the left or right side of their face. Subjects are advised to
Active Comparator Drug,Placebo Comparator No treatment
0.05% Oxymetazoline hydrochloride ,Normal saline solution

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18-45 years diagnosed by a dermatologist for mild to severe post acne erythema according to Clinician erythema assessment criteria. 2. Subjects who are informed in detail about the research study and express their interests in participation. 3. Subjects with redness scores from the VISIA differed by no more than 10% on both sides of the face.

Exclusion criteria

Exclusion criteria: 1. Subjects with a history of rosacea or other active dermatitis on the treatment site. 2. Previously known allergic reaction to oxymetazoline 3. Subjects with a past medical history of hypertension, asthma, cardiovascular disease, cerebrovascular disease, vascular disease, close angle glaucoma, hypotension, or postural hypotension. 4. Female subjects who are currently in pregnancy or breastfeeding 5. Subjects who had previously treated post acne erythema with topical medications such as azelaic acid, or other facial procedures such as lasers, injections, or any chemical treatment within three months before study enrollment.

Design outcomes

Primary

MeasureTime frame
Number of post acne erythema leision week 0, 2,4, 8, 12 PAE leision counts

Secondary

MeasureTime frame
Erythema score week 0, 2,4, 8, 12 Visia image analysis for erythema score evaluation,Erythema score week 0, 2,4, 8, 12 Chroma meter CR-400,Erythema Score week 0, 2,4, 8, 12 Clinician erythema assessment scale,Adverse effect week 0, 2,4, 8, 12 number of events,Satisfaction score after treatment week 0, 2,4, 8, 12 Subject's assessment by visual analogue scales(VAS)

Countries

Thailand

Contacts

Public ContactChanat Kumtornrut

Division of Dermatology, Faculty of Medicine, Chulalongkorn university

chanat_1@yahoo.com66814594965

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026