Clinical Trial on the Effects and Side Effects of ProOxy in the Treatment of Acne
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
1 other identifier
interventional
50
1 country
2
Brief Summary
This study was conducted to determine the effects and side effects of ProOxy facial spray in the treatment of acne.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 6, 2012
CompletedFirst Posted
Study publicly available on registry
September 10, 2012
CompletedSeptember 10, 2012
September 1, 2012
5 months
September 6, 2012
September 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
4,8,12 weeks post application of the spray
Study Arms (1)
ProOxy, Effects and Side Effects in treating acne
EXPERIMENTALPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medivet Pty Ltdlead
Study Sites (2)
Mary Chile General Hospital
Manila, National Capital Region, Philippines
Far Eastern University Hospital, Dept of Family Medicine
Quezon City, National Capital Region, Philippines
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2012
First Posted
September 10, 2012
Study Start
October 1, 2009
Primary Completion
March 1, 2010
Study Completion
September 1, 2011
Last Updated
September 10, 2012
Record last verified: 2012-09