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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01682200
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : September 10, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: ProOxy Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: ProOxy, Effects and Side Effects in treating acne
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
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.
Other Name: 15% Oxygen solution spray

Primary Outcome Measures :
  1. Changes in the appearances,sizes of the acne lesions as well as the disappearance of acne on the face. [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01682200

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Mary Chile General Hospital
Manila, Metro Manila, Philippines
Far Eastern University Hospital, Dept of Family Medicine
Quezon City, Metro Manila, Philippines
Sponsors and Collaborators
Medivet Pty Ltd

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Responsible Party: Medivet Pty Ltd Identifier: NCT01682200    
Other Study ID Numbers: PaspaPharma-04
First Posted: September 10, 2012    Key Record Dates
Last Update Posted: September 10, 2012
Last Verified: September 2012
Keywords provided by Medivet Pty Ltd:
facial acne
acne vulgaris
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases