Completed
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
What is being tested
ProOxy
Drug
Who is being recruted
Hemic and Lymphatic Diseases+12
+ Immune System Diseases
+ Immunoproliferative Disorders
From 18 to 40 Years
+9 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: October 2009
Summary
Principal SponsorMedivet Pty Ltd
Last updated: September 10, 2012
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2009
Actual date on which the first participant was enrolled.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.
Principal SponsorMedivet Pty Ltd
Last updated: September 10, 2012
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 40 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeSebaceous Gland DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAcneiform EruptionsAcne VulgarisLymphoma, Follicular
Criteria
4 inclusion criteria required to participate
patients who are at least 18 years of age
patients who are willing to follow instructions on both the Patch Test Part one and Part Two procedures and to follow scheduled visits
patients who have normal and disease free skin at the dorsal surface of the upper arm
patients with acne on their faces only
5 exclusion criteria prevent from participating
patients with history of contact dermatitis, dermatographism or anaphylaxis
patients with history of eczematous and inflammatory dermatitis, seborrheic dermatitis and psoriasis
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 systemic illnesses(such as but not limited to heart disease, hypertension, diabetes, cancer, liver disease, kidney disease)
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
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.
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Far Eastern University Hospital, Dept of Family Medicine
Quezon City, PhilippinesCompleted2 Study Centers