AcnePhase 4NCT00913185
Comparison Study of Topical Acne Regimens
A Phase 4 study testing Acne Free, Proactiv in people with Acne, run by MedDerm Associates at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of two over the counter acne products in subjects with moderate severity acne vulgaris. The two products being compared in this study are Acne Free "Severe Acne Line" manufactured by University Medical Products, and Proactiv® manufactured by Guthy-Renker. Read more about this study
- Who is it for?
- Ages 13 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- Acne Free, Proactiv
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Feb 2008
- Phase
- Phase 4
- 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 13 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects and/or subjects' legal guardians who understand and are willing to sign an Informed Consent Form, an Assent Form if indicated, and a HIPAA Authorization Form.
- Subjects who have received the permission of a parent or guardian to participate in this study or cannot be classified as a minor, under the age of 18 years.
- Male and female subjects between the ages of 13 and 45 years and in generally good health, as determined by a Medical History Form.
- Subjects with moderately-severe acne vulgaris of the face and neck as determined and defined by baseline lesion counts (see Definition: Acne Severity above).
- Subjects who have completed a Medical History Form.
- Subjects who have not used oral acne medications for 1 month prior to start of study, and topical acne medications 1 week prior to start of study.
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- Subjects who agree not to use any acne medication during the study except for the test materials given to them.
- Subjects who agree not to use any make-up that contains acne treatment additives, such as benzoyl peroxide, salicylic acid or retinol.
- Subjects who are willing to be photographed and video-recorded during study visits and willing to sign photographic release forms.
- Subjects who exhibit dependability and intelligence in following directions.
Who cannot join
- Subjects who are pregnant or lactating.
- Subjects with known allergies to cosmetic, toiletry, or acne treatment products.
- Subjects who are sensitive to any of the ingredients in the test articles.
- Subjects who have participated in a facial treatment study within 3 weeks of study initiation.
- Subjects exhibiting acute or chronic dermatological, medical, and/or physical conditions which would preclude application of the test materials and/or influence the outcome of the study.
- Subjects who are unable to sit quietly for 15 minutes to acclimate to ambient temperature and humidity conditions in the laboratory.
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- Male subjects who do not have a full beard.
- Subjects who cannot stop usage of oral acne mediation 1 month prior to study start, and topical acne medications 1 week prior to study start.
- Subjects taking routine high dosage anti-inflammatory medications (aspirin, ibuprofen).
- Subjects who must use oral corticosteroids and/or oral immunosuppressive drugs (steroid inhalers or decongestant nose drops and/or eye drops are permitted).
- Any condition for which the Investigator determines that the subject could be placed under undo risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acne Free vs. Proactiv for the Treatment of Moderately Severe Acne Vulgaris
The purpose of this study is to compare the effectiveness of two over the counter acne products in subjects with moderate severity acne vulgaris. The two products being compared in this study are Acne Free "Severe Acne Line" manufactured by University Medical Products, and Proactiv® manufactured by Guthy-Renker.
Read the detailed description
You will receive a study drug for the 8 week study. No subject will be given a placebo (an inactive substance) during treatment.The study drugs (over the counter acne medications) have been previously tested and their safe use has been established. However, not all risks or side effects are known. In rare cases of allergy, side effects may be life threatening.The most common side effects of this study drug are:
- Dry skin
- Peeling skin
- Red skin
- Burning or tingling (temporary)
- Conditions
- Acne
- Being tested
- Acne Free, Proactiv
- Keywords
- Acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acne Free, ProactivDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startDec 2006
- Primary completionDec 2006
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedDerm Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Michelle Pelle, M.D., MedDerm Associates
- Investigators
- Michelle T Pelle, M.D., Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913185
- Sponsor's protocol ID
- 1021
- Status last verified
- Jun 2014
- First submitted
- 1 Mar 2007
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acne Free vs. Proactiv for the Treatment of Moderately Severe Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00913185
- Acronym / sponsor ID
- 1021
- Conditions
- Acne
- Keywords
- Acne
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- MedDerm AssociatesIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 4 Jun 2009 (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 is to compare the effectiveness of two over the counter acne products in subjects with moderate severity acne vulgaris. The two products being compared in this study are Acne Free "Severe Acne Line" manufactured by University Medical Products, and Proactiv® manufactured by Guthy-Renker.
Detailed description
You will receive a study drug for the 8 week study. No subject will be given a placebo (an inactive substance) during treatment.The study drugs (over the counter acne medications) have been previously tested and their safe use has been established. However, not all risks or side effects are known. In rare cases of allergy, side effects may be life threatening.The most common side effects of this study drug are:
- Dry skin
- Peeling skin
- Red skin
- Burning or tingling (temporary)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 13 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Subjects and/or subjects' legal guardians who understand and are willing to sign an Informed Consent Form, an Assent Form if indicated, and a HIPAA Authorization Form.
- Subjects who have received the permission of a parent or guardian to participate in this study or cannot be classified as a minor, under the age of 18 years.
- Male and female subjects between the ages of 13 and 45 years and in generally good health, as determined by a Medical History Form.
- Subjects with moderately-severe acne vulgaris of the face and neck as determined and defined by baseline lesion counts (see Definition: Acne Severity above).
- Subjects who have completed a Medical History Form.
Key exclusion criteria (11 listed)
- Subjects who are pregnant or lactating.
- Subjects with known allergies to cosmetic, toiletry, or acne treatment products.
- Subjects who are sensitive to any of the ingredients in the test articles.
- Subjects who have participated in a facial treatment study within 3 weeks of study initiation.
- Subjects exhibiting acute or chronic dermatological, medical, and/or physical conditions which would preclude application of the test materials and/or influence the outcome of the study.
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 |
|---|---|---|
| Acne Free, Proactiv | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2014.
- Related InfoLink provided by the sponsor.
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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.
Michelle T Pelle, M.D. principal investigator
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acne Free, Proactiv in people with Acne, run by MedDerm Associates at 1 site in United States.
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 10 inclusion and 11 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 24 Jun 2014. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
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 24 Jun 2014.