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

Phase 4
Completed
Conditions
Patients with mild to severe post acne erythema according to Clinician erythema assessment criteria
Post acne erythema, Oxymetazoline hydrochloride
Registration Number
TCTR20211207004
Lead Sponsor
/A
Brief Summary

Our study demonstrated that the OxH 0.05% solution is well-tolerated, safe, and effective for reducing PAE without a rebound effect. We proposed that this over-the-counter drug for nasal congestion could be an alternative treatment for PAE.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
30
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
umber of post acne erythema leision week 0, 2,4, 8, 12 PAE leision counts
Secondary Outcome Measures
NameTimeMethod
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)
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