Back to resultsClinical Trial on the Effects and Side Effects of ProOxy in the Treatment of Acne
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 1
Locations
Philippines
Study Type
Interventional
Intervention
ProOxy
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring moderate, facial acne, acne vulgaris
Eligibility Criteria
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.
Sites / Locations
- Mary Chile General Hospital
- Far Eastern University Hospital, Dept of Family Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ProOxy, Effects and Side Effects in treating acne
Arm Description
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.
Outcomes
Primary Outcome Measures
Changes in the appearances,sizes of the acne lesions as well as the disappearance of acne on the face.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01682200
Brief Title
Clinical Trial on the Effects and Side Effects of ProOxy in the Treatment of Acne
Official Title
An Open Label Pilot Clinical Trial on the Efficacy and Safety of ProOxy Facial Spray (Topical 15% Oxygen Solution) in the Treatment of Moderate Facial Acne Vulgaris Among Filipino Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medivet Pty Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
moderate, facial acne, acne vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ProOxy, Effects and Side Effects in treating acne
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ProOxy
Other Intervention Name(s)
15% Oxygen solution spray
Intervention Description
Clean the face with ProOxy facial wash before spraying ProOxy on the face enough to wet it twice daily, upon waking up and before bedtime.
Primary Outcome Measure Information:
Title
Changes in the appearances,sizes of the acne lesions as well as the disappearance of acne on the face.
Description
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.
Time Frame
4,8,12 weeks post application of the spray
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Mary Chile General Hospital
City
Manila
State/Province
Metro Manila
Country
Philippines
Facility Name
Far Eastern University Hospital, Dept of Family Medicine
City
Quezon City
State/Province
Metro Manila
Country
Philippines
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial on the Effects and Side Effects of ProOxy in the Treatment of Acne
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