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Completed

NCT Number: NCT01682200

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

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

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mary Chile General Hospital, Manila, National Capital Region, Philippines

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ProOxy

Drug

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 names: 15% Oxygen solution spray

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medivet Pty Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Sep 10, 2012
Registry last updated
Sep 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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