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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medivet Pty Ltd
ClinicalTrials.gov Identifier:
NCT01682200
First received: September 6, 2012
Last updated: September 7, 2012
Last verified: September 2012

September 6, 2012
September 7, 2012
October 2009
March 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01682200 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acne Vulgaris
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
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.
Intervention: Drug: ProOxy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2011
March 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT01682200
PaspaPharma-04
No
Medivet Pty Ltd
Medivet Pty Ltd
Not Provided
Not Provided
Medivet Pty Ltd
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP