Acne VulgarisPhase 4NCT01047189

Adherence to Study Medication Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris

A Phase 4 study testing clindamycin phosphate 1.2% and tretinoin 0.025%, clindamycin 1% gel and tretinoin 0.025% cream in people with Acne Vulgaris, run by Wake Forest University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this research study is to evaluate the effectiveness of two different types of topical acne medication. This study will help to determine if one combined medication results in better acne improvement than two separate medications for acne. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Acne Vulgaris
What is being tested?: clindamycin phosphate 1.2% and tretinoin 0.025%, clindamycin 1% gel and tretinoin 0.025% cream
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: Mar 2009to Oct 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Males or Females 12 years of age or older with a diagnosis of mild to moderate acne vulgaris.
Subjects must sign written informed consent and agree to come for all study visits.

Who cannot join

Use of experimental drugs within 1 month prior to initiation of study therapy.
Pregnant and nursing females will not be allowed in the study, and females of childbearing potential will have a pregnancy test at baseline. Females of childbearing potential must agree to use approved birth control methods for the duration of the study.
Use of systemic retinoids within 2 months of enrollment, use of any topical retinoids, systemic antibiotics, nicotinamide, systemic steroids or any other medication that may confound the results of the study within 1 month prior to start of the study
Use of any other topical medications for acne, including cosmetics containing retinol, within 2 weeks prior to study entry.
Any skin condition or disease that may require concurrent therapy or may confound the evaluation;
History of hypersensitivity to any of the formulation components;

Show all 11Show fewer

Facial skin cancer or facial actinic keratosis;
Use of any photosensitizing agents.
Use of isotretinoin within the last 6 months.
Chemical peels, microdermabrasion or laser resurfacing within 3 months of study entry.
Crohns disease, ulcerative colitis, or have developed colitis with past antibiotic use.

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest University Health Sciences, Dermatology
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Adherence to ZIANA (Clindamycin Phosphate 1.2% With Tretinoin 0.025%)Gel Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris

Conditions: Acne Vulgaris
Being tested: clindamycin phosphate 1.2% and tretinoin 0.025%, clindamycin 1% gel, tretinoin 0.025% cream
Keywords: Mild to moderate acne vulgaris
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

clindamycin phosphate 1.2% and tretinoin 0.025%Drug
Also called Ziana
applied once daily for 12 weeks
clindamycin 1% gelDrug
Topical clindamycin applied each morning for 12 weeks
tretinoin 0.025% creamDrug
Tretinoin 0.025% cream each evening for 12 weeks

Study groups in NCT01047189
Study group	Role	What they receive
1	Experimental	Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks Receives: Drug: clindamycin phosphate 1.2% and tretinoin 0.025%
2	Active comparator	Generic clindamycin 1% gel plus tretinoin 0.025% cream Receives: Drug: clindamycin 1% gel; Drug: tretinoin 0.025% cream

What is being measured

The primary outcome is the main question the study is designed to answer.

Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne
Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap
Measured: 12 weeks

Secondary outcomes (1)

The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count
Measured: Baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Oct 2009

First posted12 Jan 2010 (estimated)
Study startMar 2009
Primary completionOct 2009
Study completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01047189
Sponsor's protocol ID: IRB00007137
Status last verified: Aug 2018
First submitted: 11 Jan 2010
Last updated: 10 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adherence to ZIANA (Clindamycin Phosphate 1.2% With Tretinoin 0.025%)Gel Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris
ClinicalTrials.gov ID: NCT01047189
Acronym / sponsor ID: IRB00007137
Conditions: Acne Vulgaris
Keywords: Mild to moderate acne vulgaris
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Wake Forest UniversityUniversity, hospital or other
Collaborators: Medicis Pharmaceutical Corporation
Study start: Mar 2009
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 12 Jan 2010 (estimated)
Results: Posted 17 Oct 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: clindamycin phosphate 1.2% and tretinoin 0.025%Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
2	Active comparator	Drug: clindamycin 1% gel, Drug: tretinoin 0.025% creamGeneric clindamycin 1% gel plus tretinoin 0.025% cream

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Males or Females 12 years of age or older with a diagnosis of mild to moderate acne vulgaris.
Subjects must sign written informed consent and agree to come for all study visits.

Key exclusion criteria (11 listed)

Use of experimental drugs within 1 month prior to initiation of study therapy.
Pregnant and nursing females will not be allowed in the study, and females of childbearing potential will have a pregnancy test at baseline. Females of childbearing potential must agree to use approved birth control methods for the duration of the study.
Use of systemic retinoids within 2 months of enrollment, use of any topical retinoids, systemic antibiotics, nicotinamide, systemic steroids or any other medication that may confound the results of the study within 1 month prior to start of the study
Use of any other topical medications for acne, including cosmetics containing retinol, within 2 weeks prior to study entry.
Any skin condition or disease that may require concurrent therapy or may confound the evaluation;

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
clindamycin phosphate 1.2% and tretinoin 0.025%Also: Zianaapplied once daily for 12 weeks	Drug	1
clindamycin 1% gelTopical clindamycin applied each morning for 12 weeks	Drug	2
tretinoin 0.025% creamTretinoin 0.025% cream each evening for 12 weeks	Drug	2

Primary outcome

Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne
Time frame: 12 weeks
Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap

1 secondary outcome

The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count
Time frame: Baseline to 12 weeks

Results and safety

Results posted to the registry on 17 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ziana Gel	13	9
Clindamycin Plus Tretinoin Applied Separately	13	13

Primary outcome: Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne

Time frame: 12 weeks. Median (Full Range). Unit: Percent of doses

Measure	Ziana Gel n = 13	Clindamycin Plus Tretinoin Applied Separately n = 13
Value	88 (13 to 115)	61 (8 to 95)

Population analysed: All patients were analyzed up to end of treatment or last visit.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ziana Gel	0 of 13 (0%)	1 of 13 (7.7%)	Not reported
Clindamycin Plus Tretinoin Applied Separately	0 of 13 (0%)	0 of 13 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruiting
A Single-Center, Open-Label Study to Assess the Efficacy and Tolerability of a Brightening Serum in Skin of Color Patients With Post Inflammatory Hyperpigmentation
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RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
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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.

Steven R Feldman, MD, Ph.D principal investigator

Wake Forest University Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 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 10 Sep 2018. 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?

Yes. Results are posted in the registry (first posted 17 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01047189.

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 2018.