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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
History of Changes
  Purpose

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


Condition Intervention Phase
Acne Vulgaris
 Drug: ProOxy
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Acne Oxygen Therapy
U.S. FDA Resources

Further study details as provided by Medivet Pty Ltd:

Primary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: October 2009
Study Completion Date: September 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682200

Locations
Philippines
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
  More Information

No publications provided

Responsible Party: Medivet Pty Ltd
ClinicalTrials.gov Identifier: NCT01682200     History of Changes
Other Study ID Numbers: PaspaPharma-04
Study First Received: September 6, 2012
Last Updated: September 7, 2012
Health Authority: Philippines: Food and Drug Administration (Formerly Known as Bureau of Food and Drugs)

Keywords provided by Medivet Pty Ltd:
moderate
facial acne
acne vulgaris

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on May 22, 2013