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

NCT00752635 | Completed Phase 4

• 1 other identifier: CR007129
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acne Vulgaris

Keywords

TriCilest; acne vulgaris

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

Interventions

Norgestimate-ethinyl estradiol; Cyproterone acetate-ethinyl estradiol DRUG

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johnson & Johnson Taiwan Ltd: lead

Related Links

• Comparison of efficacy and safety of Tricilest (norgestimate-ethinyl estradiol) and Diane-35 (cyproterone acetate-ethinyl estradiol) in the treatment of acne vulgaris

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Moxifloxacin; Cyproterone acetate, ethinyl estradiol drug combination

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Johnson & Johnson Taiwan, Ltd. Clinical Trial

  Johnson & Johnson Taiwan Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 15, 2008
• Study Start: September 1, 2004
• Study Completion: September 1, 2005
• Last Updated: May 19, 2011

Record last verified: 2010-04