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Comparison of Efficacy and Safety of Norgestimate-ethinyl Estradiol and Cyproterone Acetate-ethinyl Estradiol in the Treatment of Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Norgestimate-ethinyl estradiol; Cyproterone acetate-ethinyl estradiol
Sponsored by
Johnson & Johnson Taiwan Ltd
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring TriCilest, acne vulgaris

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female adults who were suffering from moderate acne vulgaris (grade II or III)
  • With 6 to 100 comedones (non-inflammatory lesions)
  • With 10 to 50 inflammatory lesions (papules or pustules)
  • With fewer than 5 nodules
  • Agree to condoms or diaphragm, and spermicide or any other medically approved effective barrier method of contraceptive or a nonhormonal IUD
  • Agree to take as treatment for acne only for the supplied study drug during the three month treatment phase
  • Documented by an informed consent to participate in the trial on the day before entering the study

Exclusion Criteria:

  • Patients who, in the investigator's opinion, cannot understand or follow the instructions given in the study
  • Who are pregnant or nursing
  • Who have clinical depression and are suicidal or require immediate treatment for depression
  • Who have a known hypersensitivity to any of the ingredients
  • Who are currently having significant adverse experiences from ethinyl estradiol or norgestimate
  • Who have any coexisting medical condition or are taking and concomitant to a medication that is likely to interfere with safe administration of TriCilest and/or Diane-35, in the investigator's opinion
  • Who take systemic retinoids, systemic antimicrobials, and topical acne treatments within 6 months, 1 month, and 2 weeks prior to enrollment, respectively
  • Who have any of the following contraindications to oral contraceptives: Current thrombophlebitis or thromboembolic disorders, or past history of deep vein thrombophlebitis or thromboembolic disorder, or cerebral vascular or coronary artery disease or known severe hypertension, or diabetes with vascular involvement, or known or suspected carcinoma of the breast, or known or suspected estrogen-dependent neoplasia, or undiagnosed, abnormal genital bleeding, or benign or malignant liver tumor, or have jaundice or severe liver disease, or neurovascular lesion of the eye or serious visual disturbances, or known allergic reaction or sensitivities to TriCilest or Diane 35
  • Who have taken an investigational medication within 30 days prior to enter study (or within a period of five times its half-life or the half-life of its metabolites)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The primary efficacy variable was the change form baseline to the latest available evaluation in total lesion count. The primary efficacy result of this study clearly manifested the potency of TriCilest.

    Secondary Outcome Measures

    The secondary efficacy variable (change in lesion counts) showed consistent results to the primary efficacy endpoint.

    Full Information

    First Posted
    September 11, 2008
    Last Updated
    May 18, 2011
    Sponsor
    Johnson & Johnson Taiwan Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00752635
    Brief Title
    Comparison of Efficacy and Safety of Norgestimate-ethinyl Estradiol and Cyproterone Acetate-ethinyl Estradiol in the Treatment of Acne Vulgaris
    Official Title
    Comparison of Efficacy and Safety of Tricilest (Norgestimate-ethinyl Estradiol) and Diane-35 (Cyproterone Acetate-ethinyl Estradiol) in the Treatment of Acne Vulgaris
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Taiwan Ltd

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study was to evaluate the effectiveness and safety of norgestimate-ethinyl estradiol as comparted with cyproterone acetate-ethinyl estradiol among female patients with moderate acne vulgaris.
    Detailed Description
    This study was to evaluate the efficacy and safety of TriCilest as comparted with Diane-35 among female patients with moderate acne vulgaris. The study design was double-blind, randomized, parallel and active controlled. The sponsor planned to recruit approximately 50 patients to complete 40 evaluable patients. At the end of the study, a total of 48 patients were randomized. TriCilest (noregestimate-ethinyl estradiol), 0.18mg-0.035mg or 0.215mg-0.035mg or 0.25mg-0.035mg, Oral admistration, The duration was three consecutive menstrual cycles.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acne Vulgaris
    Keywords
    TriCilest, acne vulgaris

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Norgestimate-ethinyl estradiol; Cyproterone acetate-ethinyl estradiol
    Primary Outcome Measure Information:
    Title
    The primary efficacy variable was the change form baseline to the latest available evaluation in total lesion count. The primary efficacy result of this study clearly manifested the potency of TriCilest.
    Secondary Outcome Measure Information:
    Title
    The secondary efficacy variable (change in lesion counts) showed consistent results to the primary efficacy endpoint.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    49 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female adults who were suffering from moderate acne vulgaris (grade II or III) With 6 to 100 comedones (non-inflammatory lesions) With 10 to 50 inflammatory lesions (papules or pustules) With fewer than 5 nodules Agree to condoms or diaphragm, and spermicide or any other medically approved effective barrier method of contraceptive or a nonhormonal IUD Agree to take as treatment for acne only for the supplied study drug during the three month treatment phase Documented by an informed consent to participate in the trial on the day before entering the study Exclusion Criteria: Patients who, in the investigator's opinion, cannot understand or follow the instructions given in the study Who are pregnant or nursing Who have clinical depression and are suicidal or require immediate treatment for depression Who have a known hypersensitivity to any of the ingredients Who are currently having significant adverse experiences from ethinyl estradiol or norgestimate Who have any coexisting medical condition or are taking and concomitant to a medication that is likely to interfere with safe administration of TriCilest and/or Diane-35, in the investigator's opinion Who take systemic retinoids, systemic antimicrobials, and topical acne treatments within 6 months, 1 month, and 2 weeks prior to enrollment, respectively Who have any of the following contraindications to oral contraceptives: Current thrombophlebitis or thromboembolic disorders, or past history of deep vein thrombophlebitis or thromboembolic disorder, or cerebral vascular or coronary artery disease or known severe hypertension, or diabetes with vascular involvement, or known or suspected carcinoma of the breast, or known or suspected estrogen-dependent neoplasia, or undiagnosed, abnormal genital bleeding, or benign or malignant liver tumor, or have jaundice or severe liver disease, or neurovascular lesion of the eye or serious visual disturbances, or known allergic reaction or sensitivities to TriCilest or Diane 35 Who have taken an investigational medication within 30 days prior to enter study (or within a period of five times its half-life or the half-life of its metabolites)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Taiwan, Ltd. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Taiwan Ltd
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=693&filename=CR007129_CSR.pdf
    Description
    Comparison of efficacy and safety of Tricilest (norgestimate-ethinyl estradiol) and Diane-35 (cyproterone acetate-ethinyl estradiol) in the treatment of acne vulgaris

    Learn more about this trial

    Comparison of Efficacy and Safety of Norgestimate-ethinyl Estradiol and Cyproterone Acetate-ethinyl Estradiol in the Treatment of Acne Vulgaris

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