Trials Sponsors Conditions Drugs Pricing

Conditions

MILD TO SEVERE ACNE VULGARIS

Keywords

acneZianaclindamycintretinoin

Outcome Measures

Primary Outcomes (3)

Therapeutic Equivalence
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.
12-weeks
Superiority
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.
12-Weeks
Safety
All treatment-emergent adverse events reported during the study will be summarized in order to assess safety.
12-Weeks

Study Arms (3)

CLIND PHOSPHATE (1.2%) AND TRETINOIN (0.025%) TOPICAL GEL

EXPERIMENTAL

Topical Gel Test Product

Drug: CLIND PHOSPHATE (1.2%) AND TRETINOIN (0.025%) TOPICAL GEL

ZIANA®

ACTIVE COMPARATOR

Topical Gel Reference Product

Drug: ZIANA®

Vehicle Control

PLACEBO COMPARATOR

Topical Gel Placebo

Drug: Vehicle Control

Interventions

CLIND PHOSPHATE (1.2%) AND TRETINOIN (0.025%) TOPICAL GELDrug

Topical Gel applied in the evening for 84 days

CLIND PHOSPHATE (1.2%) AND TRETINOIN (0.025%) TOPICAL GEL

ZIANA®Drug

Topical Gel applied in the evening for 84 days

ZIANA®

Eligibility Criteria

Age12 Years - 40 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

\. 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.

Sponsors & Collaborators

Actavis Mid-Atlantic LLC
Industrylead

Study Sites (1)

Lotus Labs Pvt. Ltd

Bangalore, 560 034, India

MeSH Terms

Conditions

Acne Vulgaris

Interventions

TretinoinGelsclindamycin, tretinoin drug combination

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Vitamin ARetinoidsCarotenoidsPolyenesAlkenes

Study Officials

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

Enrollment

1,225 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

December 9, 2010

First Posted

December 10, 2010

Study Start

May 2010

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (3)

CLIND PHOSPHATE (1.2%) AND TRETINOIN (0.025%) TOPICAL GEL

ZIANA®

Vehicle Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (3)

CLIND PHOSPHATE (1.2%) AND TRETINOIN (0.025%) TOPICAL GEL

ZIANA®

Vehicle Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations