AcnePhase 4NCT01206348
Combination Treatment for Moderate to Severe Acne
A Phase 4 study testing Minocycline, Clindamycin, Tretinoin, Benzoyl Peroxide in people with Acne, run by Medicis Global Service Corporation at 10 sites in United States.
Trial summary
To determine if a combination of three currently approved acne products are safe and effective for the treatment of moderate to severe acne Read more about this study
- Who is it for?
- Ages 12 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- Minocycline, Clindamycin, Tretinoin, Benzoyl Peroxide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 10 sitesUnited States
- Study dates
- Sep 2010to Jul 2011
- 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 12 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- moderate to severe acne, IGA = 3 or 4 (Investigator Global Assessment)
Who cannot join
- pregnancy and allergies
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Birmingham, Alabama
Study site
Chestnut Hill, Massachusetts
Study site
Detroit, Michigan
Study site
Henderson, Nevada
Study site
Hershey, Pennsylvania
Study site
High Point, North Carolina
Study site
Hockessin, Delaware
Study site
Nashville, Tennessee
Study site
Salt Lake City, Utah
Study site
Santa Monica, California
About this study
Official title: A Phase IV, Open-Label Study Evaluating the Use of Solodyn (Minocycline HCL Extended-Release Tablets), Ziana, and Triaz Foaming Cloths as Combination Acne Therapy Prior to Treatment With Isotretinoin
To determine if a combination of three currently approved acne products are safe and effective for the treatment of moderate to severe acne
Read the detailed description
A Phase IV, Open-Label Study Evaluating the treatment for Combination Acne Therapy.
- Conditions
- Acne
- Being tested
- Minocycline, Clindamycin, Tretinoin, Benzoyl Peroxide
- 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.
Minocycline, Clindamycin, Tretinoin, Benzoyl PeroxideDrug
Solodyn 1 tablet, Q day Ziana Gel, topical Q am Triaz FC, topical Q night
| Study group | Role | What they receive |
|---|---|---|
| Open Label Combination | Experimental | Solodyn, Ziana, Triaz FC Receives: Drug: Minocycline, Clindamycin, Tretinoin, Benzoyl Peroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients showing improvement from Baseline and Week 12
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2011
- Study completionJul 2011
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicis Global Service Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Sanstead, BSN, CCRP, Study chair, Medicis Global Service Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206348
- Sponsor's protocol ID
- MP-0104-28
- Status last verified
- Nov 2011
- First submitted
- 17 Sep 2010
- Last updated
- 30 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Open-Label Study Evaluating the Use of Solodyn (Minocycline HCL Extended-Release Tablets), Ziana, and Triaz Foaming Cloths as Combination Acne Therapy Prior to Treatment With Isotretinoin
- ClinicalTrials.gov ID
- NCT01206348
- Acronym / sponsor ID
- MP-0104-28
- Conditions
- Acne
- Keywords
- Acne
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Medicis Global Service CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 21 Sep 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.
To determine if a combination of three currently approved acne products are safe and effective for the treatment of moderate to severe acne
Detailed description
A Phase IV, Open-Label Study Evaluating the treatment for Combination Acne Therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Combination | Experimental | Drug: Minocycline, Clindamycin, Tretinoin, Benzoyl PeroxideSolodyn, Ziana, Triaz FC |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- moderate to severe acne, IGA = 3 or 4 (Investigator Global Assessment)
Key exclusion criteria (1 listed)
- pregnancy and allergies
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 |
|---|---|---|
| Minocycline, Clindamycin, Tretinoin, Benzoyl PeroxideSolodyn 1 tablet, Q day Ziana Gel, topical Q am Triaz FC, topical Q night | Drug | Open Label Combination |
Primary outcome
Proportion of patients showing improvement from Baseline and Week 12
Time frame: Week 12
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 30 Nov 2011.
Related trials for Acne
Not yet recruiting
Evaluating a Brightening Serum for Post-Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
Enrolling by invitationPhase 2/3
A Split-Face Comparative Study of Mono Threads Versus Combination With Plasma Gel for the Treatment of Post-Acne Scars
Acne
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 3
Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris
Acne Vulgaris, Acne Vulgaris on the Face
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.
Mary Sanstead, BSN, CCRP study chair
Medicis Global Service Corporation
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Minocycline, Clindamycin, Tretinoin, Benzoyl Peroxide in people with Acne, run by Medicis Global Service Corporation at 10 sites 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 1 inclusion and 1 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 30 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
What does the primary outcome measure?
Proportion of patients showing improvement from Baseline and Week 12 (time frame: Week 12). 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 30 Nov 2011.