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CompletedNCT01682200Updated Sep 10, 2012

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

A Phase 1 interventional study of ProOxy in Acne Vulgaris, sponsored by Medivet Pty Ltd. Completed at 2 sites in Philippines. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-09-10.

Sponsored by Medivet Pty Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Acne Vulgaris

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Keywords

  • moderate
  • facial acne
  • acne vulgaris
03

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.

This study's enrollment of 50 is below the median of 69 across 628 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

This is the only study on the registry with Medivet Pty Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • 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

Interventions

  • DrugProOxy

    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.

    Also known as: 15% Oxygen solution spray

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4,8,12 weeks post application of the spray

07

Study locations

2 sites
  • Mary Chile General Hospital
    Manila, Metro Manila, Philippines
  • Far Eastern University Hospital, Dept of Family Medicine
    Quezon City, Metro Manila, Philippines
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01682200
Lead sponsor
Medivet Pty Ltd
Responsible party
Sponsor
First posted
Sep 10, 2012
Start date
Oct 2009
Primary completion
Mar 2010
Completion
Sep 2011
Last update
Sep 10, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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