Acne VulgarisPhase 2NCT01180543
Acne Treatment With Active Oplon's Patches
A Phase 2 study testing Oplon Active Patch in people with Acne Vulgaris, run by Oplon-Pure Science Ltd. at 1 site in Israel.
Trial summary
The purpose of this study was to demonstrate the effect of short treatment with active OPLON patches on Acne. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Oplon Active Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to Dec 2010
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acne Vulgaris
- Over 18 years
- Signing informed consent
Who cannot join
- Active treatment of acne
- Change in hormonal therapy
- Antibiotic treatment in a week prior to the experiment
- Sensitive skin
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II- Acne Treatment With Active Patches Which Contains Azelaic Acid, Citric Acid,Salicylic Acid and 2% Ascorbic Acid
The purpose of this study was to demonstrate the effect of short treatment with active OPLON patches on Acne.
Read the detailed description
Patients with Acne Vulgaris were treated overnight with active patches. Effect is observed at the end of the treatment and 24 hours later.
- Conditions
- Acne Vulgaris
- Being tested
- Oplon Active Patch, Placebo Patch
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oplon Active PatchDevice
Patches are placed over acne lesion overnight. Treatment is a single treatment.
Placebo PatchDevice
same as active patch
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Oplon Active Patch | Active comparator | Not described Receives: Device: Oplon Active Patch |
| Placebo Comparator: Placebo patch | Placebo comparator | Not described Receives: Device: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity Score of lesion
Lesions were ranked by investigator according to severity whereas:
0-clear, 1-mild, 2-moderate, 3-sever
Measured: Severity Score of lesion [Time Frame: 24 hours following patch removal]
Secondary outcomes (1)
Severity Score of lesion
Lesions were ranked by investigator according to severity whereas:
0-clear, 1-mild, 2-moderate, 3-sever
Measured: Severity Score of lesion [Time Frame: 12 hours with the patch]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2010
- Study completionDec 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oplon-Pure Science Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Avner Shemer, M.D., Principal investigator, Laniado Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180543
- Sponsor's protocol ID
- OP002
- Status last verified
- Jun 2011
- First submitted
- 11 Aug 2010
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II- Acne Treatment With Active Patches Which Contains Azelaic Acid, Citric Acid,Salicylic Acid and 2% Ascorbic Acid
- ClinicalTrials.gov ID
- NCT01180543
- Acronym / sponsor ID
- OP002
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oplon-Pure Science Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 12 Aug 2010 (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.
The purpose of this study was to demonstrate the effect of short treatment with active OPLON patches on Acne.
Detailed description
Patients with Acne Vulgaris were treated overnight with active patches. Effect is observed at the end of the treatment and 24 hours later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Oplon Active Patch | Active comparator | Device: Oplon Active Patch |
| Placebo Comparator: Placebo patch | Placebo comparator | Device: Placebo Patch |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acne Vulgaris
- Over 18 years
- Signing informed consent
Key exclusion criteria (5 listed)
- Active treatment of acne
- Change in hormonal therapy
- Antibiotic treatment in a week prior to the experiment
- Sensitive skin
- Pregnancy
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 |
|---|---|---|
| Oplon Active PatchPatches are placed over acne lesion overnight. Treatment is a single treatment. | Device | Active Comparator: Oplon Active Patch |
| Placebo Patchsame as active patch | Device | Placebo Comparator: Placebo patch |
Primary outcome
Severity Score of lesion
Time frame: Severity Score of lesion [Time Frame: 24 hours following patch removal]
Lesions were ranked by investigator according to severity whereas: 0-clear, 1-mild, 2-moderate, 3-sever
1 secondary outcome
Severity Score of lesion
Time frame: Severity Score of lesion [Time Frame: 12 hours with the patch]
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 Jun 2011.
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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.
Avner Shemer, M.D. principal investigator
Laniado Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oplon Active Patch in people with Acne Vulgaris, run by Oplon-Pure Science Ltd. at 1 site in Israel.
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 3 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 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Severity Score of lesion (time frame: Severity Score of lesion [Time Frame: 24 hours following patch removal]). 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 Jun 2011.