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

NCT ID: NCT01682200

Last Updated: 2012-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Acne Vulgaris

Keywords

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moderate facial acne acne vulgaris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ProOxy

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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15% Oxygen solution spray

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medivet Pty Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mary Chile General Hospital

Manila, National Capital Region, Philippines

Site Status

Far Eastern University Hospital, Dept of Family Medicine

Quezon City, National Capital Region, Philippines

Site Status

Countries

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Philippines

Other Identifiers

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PaspaPharma-04

Identifier Type: -

Identifier Source: org_study_id