Bioequivalence Study Comparing Clindamycin Phosphate (1.2%) and Tretinoin (0.025%) Topical Gel to Ziana and Placebo

This study has been completed.
Sponsor:
Information provided by:
Actavis Mid-Atlantic LLC
ClinicalTrials.gov Identifier:
NCT01257906
First received: December 9, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

ZIANA® (clindamycin phosphate 1.2% and tretinoin 0.025%) gel, marketed by Medicis, The Dermatology Company®, is a safe and effective topical therapy used for the treatment of acne vulgaris. Actavis Mid-Atlantic LLC has developed a generic formulation of clindamycin phosphate (1.2%) and tretinoin (0.025%) topical gel and the current study is designed to evaluate the bioequivalence of this formulation to ZIANA®.


Condition Intervention
MILD TO SEVERE ACNE VULGARIS
Drug: CLIND PHOSPHATE (1.2%) AND TRETINOIN (0.025%) TOPICAL GEL
Drug: ZIANA®
Drug: Vehicle Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, VEHICLE-CONTROLLED, PARALLEL-GROUP STUDY COMPARING CLINDAMYCIN PHOSPHATE (1.2%) AND TRETINOIN (0.025%) TOPICAL GEL (ACTAVIS MID-ATLANTIC LLC) TO ZIANA® (CLINDAMYCIN PHOSPHATE 1.2% AND TRETINOIN 0.025%) GEL (MEDICIS, THE DERMATOLOGY COMPANY®) AND BOTH ACTIVE TREATMENTS TO CLINDAMYCIN PHOSPHATE (1.2%) AND TRETINOIN (0.025%) TOPICAL GEL PLACEBO (ACTAVIS MID-ATLANTIC LLC) IN THE TREATMENT OF MILD TO SEVERE ACNE VULGARIS

Resource links provided by NLM:


Further study details as provided by Actavis Mid-Atlantic LLC:

Primary Outcome Measures:
  • Therapeutic Equivalence [ Time Frame: 12-weeks ] [ Designated as safety issue: No ]
    The primary equivalence comparison is that between the test and reference products for the mean percent change from baseline in the inflammatory lesion counts and the non-inflammatory lesion counts at Visit 5.

  • Superiority [ Time Frame: 12-Weeks ] [ Designated as safety issue: No ]
    The primary superiority evaluations are the comparisons between each active treatment and the vehicle control relative to the mean percent change in the inflammatory lesion counts and the non-inflammatory lesion counts.

  • Safety [ Time Frame: 12-Weeks ] [ Designated as safety issue: Yes ]
    All treatment-emergent adverse events reported during the study will be summarized in order to assess safety.


Enrollment: 1225
Study Start Date: May 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CLIND PHOSPHATE (1.2%) AND TRETINOIN (0.025%) TOPICAL GEL
Topical Gel Test Product
Drug: CLIND PHOSPHATE (1.2%) AND TRETINOIN (0.025%) TOPICAL GEL
Topical Gel applied in the evening for 84 days
Active Comparator: ZIANA®
Topical Gel Reference Product
Drug: ZIANA®
Topical Gel applied in the evening for 84 days
Placebo Comparator: Vehicle Control
Topical Gel Placebo
Drug: Vehicle Control
Topical Gel applied in the evening for 84 days.

  Eligibility

Ages Eligible for Study:   12 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Male or nonpregnant female patients must be between the ages of 12 and 40 years old inclusive. 2. Patients who are 18 years of age or older must have provided IRB/IEC approved written informed consent. Patients between the ages of 12 to 17 years of age must have provided IRB/IEC approved written assent; this written assent must be accompanied by an IRB/IEC approved written informed consent from the patient's legally acceptable representative (i.e., parent or guardian). In addition, all patients or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization, if applicable. 3. Patients must have a definite clinical diagnosis of mild to severe acne vulgaris (Grade 2, Grade 3 or Grade 4 on the IGE). 4. Patients must have a minimum of 20 and a maximum of 100 facial inflammatory lesions at baseline. Patients must also have a minimum of 25 and a maximum of 100 non-inflammatory lesions (i.e., open and closed comedones) at baseline. Patients may have no more than two (2) nodulo-cystic lesions at baseline. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. Lesions involving the eyes, angles of the nose (i.e., the lines around your nostrils and under the nostrils) and scalp should be excluded from the count. Patients may have acne lesions on other areas of the body (e.g., on the back). 5.Female patients of childbearing potential must have been using accepted methods of birth control or must agree to continue to practice abstinence, from 30 days prior to study entry to 30 days after the last administration of study drug. All female patients are considered to be of childbearing potential unless they have been surgically sterilized or have been postmenopausal for at least 1 year. Abstinence is an acceptable method of birth control. Alternatively, any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®) Depo-Provera®, double barrier methods (e.g., condom and spermicide) or IUD. Female patients must have a negative urine pregnancy test at baseline. A negative result of a pregnancy test having a minimum sensitivity of at least 50 mIU/ml for hCG should be obtained. 6. All male patients must agree to use accepted methods of birth control with their partners, from the day of the first dose administration to 30 days after the last administration of study drug. Abstinence is an acceptable method of birth control. Alternatively, any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®), Depo-Provera®, double barrier methods (e.g., condom and spermicide) or IUD. 7. Patients must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits. 8. Patients must be willing to refrain from using any treatments for acne vulgaris, including antibiotics, other than the investigational product, for acne present on the face. Patients may use other topical acne treatments that do not have significant or measurable systemic absorption for treatment of acne of the back, shoulders and chest (e.g., benzoyl peroxide, salicylic acid). 9. Patients must be in good health and free from any clinically significant disease. 10. Patients who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to not change make-up brand/type or frequency of use throughout the study.

Exclusion Criteria:

1. Female patients who are pregnant, nursing or planning to become pregnant during study participation (Visit 1 through Visit 5) will be excluded from study participation. 2. Patients who have a known hypersensitivity to clindamycin phosphate or tretinoin or their excipients will be excluded from study participation. 3. Patients who have conditions that may interfere with the evaluation of acne vulgaris. Such conditions include, but are not limited to the following: rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne or folliculitis; carcinoid syndrome; squamous cell carcinoma; mastocytosis; acneiform eruptions caused by make-up or medication; bacterial folliculitis; facial psoriasis; and facial eczema. 4. Patients who have acne congoblata, acne fulminans, and secondary acne (e.g., chloracne and drug induced acne) will be excluded from participation. 5. Patients who have been treated with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs within 30 days prior to baseline will be excluded from study participation. 6. Patients who have been treated with prescription and/or over-the-counter topical medications for the treatment of acne vulgaris including antibiotics, topical corticosteroids,,α-hydroxy/glycolic acid, benzoyl peroxide, or topical anti-inflammatory medications on the face within 14 days prior to baseline will be excluded from study participation. 7. Patients who have used erythromycin or erythromycin containing products in any form within 30 days prior to study entry (i.e., Visit 1) will be excluded from study participation. 8. Patients who are currently taking or have been treated with corticosteroids (including intranasal and inhaled corticosteroids) within 30 days prior to baseline will be excluded from study participation. 9. Patients who have started hormonal therapy or changed the dosage of their hormonal therapy within 3 months prior to baseline will be excluded from study participation. The dosage and frequency of use of any hormonal therapy started greater than 3 months prior to baseline must remain unchanged throughout the study (Visit 1 through Visit 5). Hormonal treatments include, but are not limited to, estrogenic and progestational agents such as birth control pills. 10. Patients who use androgen receptor blockers for acne (such as spironolactone or flutamide) will be excluded from study participation. 11. Patients who have received oral retinoids (e.g., isotretinoin) within 180 days prior to study entry,or have used therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed) within 180 days prior to study entry, or have applied topical retinoids (e.g., tretinoin, tazarotene, adapalene) to the face within the 30 days prior to baseline will be excluded from study participation. 12. Patients who have received radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline will be excluded from study participation. 13. Patients who have unstable medical disorders that are clinically significant or life-threatening diseases will be excluded from study participation. 14. Patients who have on-going malignancies requiring systemic treatment will be excluded from study participation. In addition, patients who have any malignancy of the skin of the facial area will be excluded from study participation. 15. Patients who have facial hair will be excluded from study participation. Unacceptable facial hair includes, but is not limited to, beards, and long side-burns. A well-trimmed mustache is acceptable. Patients who have performed wax epilation of the face within 14 days prior to baseline will also be excluded from study participation. 16. Patients who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold, will be excluded from study participation. 17. Patients who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids and cocaine) as judged by history will be excluded from study participation. 18. Patients who have participated in an investigational drug study (i.e., patients have been treated with an investigational drug) within 30 days prior to baseline will be excluded from study participation. Patients who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion. 19. Patients who have been previously enrolled in this study will be excluded from study participation. 20. Patients who have had within 30 days prior to baseline or during the study cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, or x-ray therapy will be excluded from study participation. 21. Patients who have had laser therapy, and electrodesiccation to the facial area within 180 days prior to study entry will be excluded from participation. 22. Patients who have had cosmetic procedures (e.g., facials) which may affect the efficacy and safety profile of the investigational product within 14 days prior to study entry will be excluded from participation. 23. Patients who have had general anesthesia for any reason and patients who have received neuromuscular blocking agents within 14 days prior to study entry will be excluded from study participation. 24. Patients who have a history of Crohn's disease, ulcerative colitis, regional enteritis, antibiotic-associated colitis will be excluded from study participation. 25. Patients who have a baseline local irritation score of 3 (severe, marked/intense) as scored using the Application Site Reaction Scale (Section 5.2) will be excluded from participation.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257906

Locations
India
Lotus Labs Pvt. Ltd
Bangalore, India, 560 034
Sponsors and Collaborators
Actavis Mid-Atlantic LLC
Investigators
Principal Investigator: Madhuri Tadepalli, MD Skin and Cosmetology Clinic
Principal Investigator: Bela J. Shah, MD BJ Medical College and Civil Hospital
Principal Investigator: Abir Saraswat, MD Indu Shree Clinic
Principal Investigator: Manoj K. Parekh, MD Bhagwan Mahaveer Jain Hospital
Principal Investigator: V. R. Sardesai, MD Sardesai Clinic
Principal Investigator: Girish BS, MD Justice KS Hedge Charitable Hospital
Principal Investigator: Leelavathy B., MD Bowring & Lady Curzon Hospital
Principal Investigator: Rajkumar V., MD Dhanawantari Polyclinic
Principal Investigator: Mukta Sachdev, MD MS Clinical Research Pvt. Ltd.
Principal Investigator: Anilkumar Malik, MD G.M Modi Hospital
Principal Investigator: Narayana Rao, MD Skin and Cosmetology
Principal Investigator: Guru Prasad, MD Dayal Clinic
Principal Investigator: Jayadev Betkerur, MD J.S.S. Medical College Hospital
Principal Investigator: Bhanuja Rani, MD GVK Clinic
Principal Investigator: Mishra RS, MD Skin Care and Cosmetology Centre
Principal Investigator: Hemanji R. Jerajani, MD L.T.M. Medical College & General Hospital
Principal Investigator: BV Ramachandra, MD Andhra Medical College
Principal Investigator: Akhilesh Agarwal, MD Twacha Skin and Hair Clinic
Principal Investigator: Deepak Kotkar, MD Dr. Deepak Kotkar Clinic
Principal Investigator: Alur S. Kumar, MD Owaisi Hospital & Research Centre
Principal Investigator: Jayesh Kothari, MD Skin Clinic
Principal Investigator: MG Gopal, MD Kempegowda Institute of Medical Sciences
Principal Investigator: D. N. Balraj, MD Rajbal Skin Clinic
Principal Investigator: Meethesh Agrawal, MD Skin Clinic
Principal Investigator: Ravi M. Rathod, MD Skin Care Centre
Principal Investigator: Ranjan C. Raval, MD Smt. NHL Medical College and V.S. Hospital
Principal Investigator: V. K. Somani, MD Somani Skin and Cosmetology Institute
Principal Investigator: Kailash Bhatia, MD Bhatia Skin, Laser, & Cosmetic Center
Principal Investigator: Bhavesh K. Swarnakar, MD Swarnakar's Clinic
Principal Investigator: Jayakar Thomas, MD J.T. Skin Care Centre
Principal Investigator: Karigi Siddalingappa, MD Vijayanagara Institute Of Medical Sciences
Principal Investigator: DVS Pratap, MD Durga Bai Deshmukh Hospital and Research Center
Principal Investigator: Amit Madan, MD Madan's Skin Care Centre
Principal Investigator: Rajeev Agarwal, MD MV Hospital and Research Center
Principal Investigator: Ramesh Bhat, MD Father Muller Medical College and Hospital
Principal Investigator: Ravindra B P, MD Raga's Skin Care
Principal Investigator: S. Sacchidananda, MD CITI Hospital
Principal Investigator: Veena Patil, MD Medi Derma Hospital
Principal Investigator: Dinesh V Deshpande, MD Deshpande Skin Clinic
Principal Investigator: Ajay J Deshpande, MD Dr. Ajay Deshpande's Clinic
Principal Investigator: Sudhakar Grandhi, MD Medipoint Hospitals Pvt. Ltd.
Principal Investigator: Anirudh D. Gulanikar, MD Gulanikar Skin Clinic
Principal Investigator: Prashant K Palwade, MD Keshav Skin and Hair Clinic
Principal Investigator: Uday Kulkarni, MD Skin Care and Cosmetology Clinic
Principal Investigator: Amit Luthra, MD Ishira Skin Clinic
Principal Investigator: K Venkatachalam, MD Sri Gayathri Skin Care and Hair Transplant Centre
Principal Investigator: Apoorva Jain, MD Max Skin Care Centre
Principal Investigator: Pradyumna P Vaidya, MD Clinical Development Centre Pvt. Ltd.
Principal Investigator: Prachi A Matte, MD Derma Lazer Clinic
Principal Investigator: Vikrant A Saoji, MD Dr. Vikrant Saoji Skin Clinic
Principal Investigator: Archana M Goyal, MD Laser and Skin Clinic Jaipur
Principal Investigator: Anshu Jain, MD Skin Clinic
Principal Investigator: Vijay Zawar, MD Skin Clinic
Principal Investigator: Sushil Y Pande, MD Sparsh Hospital and Poly Clinic
Principal Investigator: Sujata Sengupta, MD BP Poddar Hospital and Medical Research Limited
Principal Investigator: Kote R Purushottam, MD Skin Care Clinic
Principal Investigator: Kiran Godse, MD Shree Skin Centre and Pathology Laboratory
  More Information

No publications provided

Responsible Party: Christine M. Winslow, Ph.D., Director Clinical Development, Actavis Mid-Atlantic LLC
ClinicalTrials.gov Identifier: NCT01257906     History of Changes
Other Study ID Numbers: Acta/Clin-Tret/2009
Study First Received: December 9, 2010
Last Updated: December 9, 2010
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India

Keywords provided by Actavis Mid-Atlantic LLC:
acne
Ziana
clindamycin
tretinoin

Additional relevant MeSH terms:
Tretinoin
Acne Vulgaris
Acneiform Eruptions
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Keratolytic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014