Acne VulgarisPhase 1NCT01682200
Clinical Trial on the Effects and Side Effects of ProOxy in the Treatment of Acne
A Phase 1 study testing ProOxy in people with Acne Vulgaris, run by Medivet Pty Ltd at 2 sites in Philippines.
Trial summary
This study was conducted to determine the effects and side effects of ProOxy facial spray in the treatment of acne. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- ProOxy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesPhilippines
- Study dates
- Oct 2009to Sep 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Philippines2 sites
Mary Chile General Hospital
Manila, National Capital Region
Far Eastern University Hospital, Dept of Family Medicine
Quezon City, National Capital Region
About this study
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
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.
- Conditions
- Acne Vulgaris
- Being tested
- ProOxy
- Keywords
- moderate, facial acne, acne vulgaris
- Medical subject headings
- Acne Vulgaris, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProOxyDrug
Also called 15% Oxygen solution spray
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.
| Study group | Role | What they receive |
|---|---|---|
| ProOxy, Effects and Side Effects in treating acne | Experimental | 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. Receives: Drug: ProOxy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4,8,12 weeks post application of the spray
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medivet Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682200
- Sponsor's protocol ID
- PaspaPharma-04
- Status last verified
- Sep 2012
- First submitted
- 6 Sep 2012
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01682200
- Acronym / sponsor ID
- PaspaPharma-04
- Conditions
- Acne Vulgaris
- Keywords
- moderate, facial acne, acne vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medivet Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 10 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to determine the effects and side effects of ProOxy facial spray in the treatment of acne.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ProOxy, Effects and Side Effects in treating acne | Experimental | Drug: ProOxyPatients 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProOxyAlso: 15% Oxygen solution sprayClean the face with ProOxy facial wash before spraying ProOxy on the face enough to wet it twice daily, upon waking up and before bedtime. | Drug | ProOxy, Effects and Side Effects in treating acne |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ProOxy in people with Acne Vulgaris, run by Medivet Pty Ltd at 2 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2012.