Adherence to Study Medication Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01047189 |
Recruitment Status :
Completed
First Posted : January 12, 2010
Results First Posted : October 17, 2011
Last Update Posted : September 10, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acne Vulgaris | Drug: clindamycin phosphate 1.2% and tretinoin 0.025% Drug: clindamycin 1% gel Drug: tretinoin 0.025% cream | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | October 2009 |
Actual Study Completion Date : | October 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
|
Drug: clindamycin phosphate 1.2% and tretinoin 0.025%
applied once daily for 12 weeks
Other Name: Ziana |
Active Comparator: 2
Generic clindamycin 1% gel plus tretinoin 0.025% cream
|
Drug: clindamycin 1% gel
Topical clindamycin applied each morning for 12 weeks Drug: tretinoin 0.025% cream Tretinoin 0.025% cream each evening for 12 weeks |
- 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
- The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count [ Time Frame: Baseline to 12 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047189
United States, North Carolina | |
Wake Forest University Health Sciences, Dermatology | |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | Steven R Feldman, MD, Ph.D | Wake Forest University Health Sciences |
Responsible Party: | Wake Forest University |
ClinicalTrials.gov Identifier: | NCT01047189 |
Other Study ID Numbers: |
IRB00007137 |
First Posted: | January 12, 2010 Key Record Dates |
Results First Posted: | October 17, 2011 |
Last Update Posted: | September 10, 2018 |
Last Verified: | August 2018 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Mild to moderate acne vulgaris |
Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases Clindamycin Clindamycin palmitate Clindamycin phosphate Tretinoin |
Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Keratolytic Agents Dermatologic Agents |