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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: ProOxy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ProOxy, Effects and Side Effects in treating acne<br>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. | Drug: ProOxy<br>* 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.<br>* Other names: 15% Oxygen solution spray;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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moderate, facial acne, acne vulgaris