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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682200
• Other study ID #: PaspaPharma-04
• Status: Completed
• Phase: Phase 1
• First received: September 6, 2012
• Last updated: September 7, 2012
• Start date: October 2009
• Est. completion date: September 2011

Study information

• Verified date: September 2012
• Source: Medivet Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Food and Drug Administration (Formerly Known as Bureau of Food and Drugs)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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.

Locations

Country	Name	City	State
Philippines	Mary Chile General Hospital	Manila	Metro Manila
Philippines	Far Eastern University Hospital, Dept of Family Medicine	Quezon City	Metro Manila

Sponsors (1)

Lead Sponsor	Collaborator
Medivet Pty Ltd

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No