Clinical Trial on the Effects and Side Effects of ProOxy in the Treatment of Acne

Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: ProOxy

• Registration Number: NCT01682200
• Lead Sponsor: Medivet Pty Ltd

Brief Summary

This study was conducted to determine the effects and side effects of ProOxy facial spray in the treatment of acne.

Detailed Description

A study on the effects and side effects of ProOxy facial spray was done. Sixty people were selected and approved to participate in this study. Pictures of the face (frontal,left side and right side) were taken upon acceptance, during and after treatment at 4,8 and 12 weeks intervals.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-03
• Study Completion: 2011-09
• Status Verified: 2012-09
• Study First Submitted: 2012-09-06
• Study First Submitted QC: 2012-09-07
• Last Update Submitted: 2012-09-07
• Study First Posted: 2012-09-10
• Last Update Posted: 2012-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patients with acne on their faces only
• patients who are at least 18 years of age
• patients who have normal and disease free skin at the dorsal surface of the upper arm.
• patients who are willing to follow instructions on both the Patch Test Part one and Part Two procedures and to follow scheduled visits.

Exclusion Criteria

• patients with systemic illnesses(such as but not limited to heart disease, hypertension, diabetes, cancer, liver disease, kidney disease)
• patients with very dark skin color, Fitzpatrick skin type V-VI, who are prone to post=inflammatory hyperpigmentation.
• patients with intake of oral medications including glucocorticoids or any immuno-suppressants or who have undergone ultraviolet phototherapy for the past 2 weeks prior to the patch test.
• patients with history of contact dermatitis, dermatographism or anaphylaxis.
• patients with history of eczematous and inflammatory dermatitis, seborrheic dermatitis and psoriasis.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ProOxy, Effects and Side Effects in treating acne	ProOxy	Patients are instructed to clean the face with ProOxy facial cleanser and then spray on the face wet enough but not dripping twice daily (upon waking up and before bedtime) for 3 months.

Primary Outcome Measures

Name	Time	Method
Changes in the appearances,sizes of the acne lesions as well as the disappearance of acne on the face.	4,8,12 weeks post application of the spray	Upon acceptance,pictures are taken and acne lesions are identified and counted and after 4,8, and 12 weeks during and after application of ProOxy.

Trial Locations

Locations (2)

Far Eastern University Hospital, Dept of Family Medicine; 🇵🇭 Quezon City, Metro Manila, Philippines

Mary Chile General Hospital; 🇵🇭 Manila, Metro Manila, Philippines