- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00752635
Comparison of Efficacy and Safety of Norgestimate-ethinyl Estradiol and Cyproterone Acetate-ethinyl Estradiol in the Treatment of Acne Vulgaris
Comparison of Efficacy and Safety of Tricilest (Norgestimate-ethinyl Estradiol) and Diane-35 (Cyproterone Acetate-ethinyl Estradiol) in the Treatment of Acne Vulgaris
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
---|
The secondary efficacy variable (change in lesion counts) showed consistent results to the primary efficacy endpoint.
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Acneiform Eruptions
- Sebaceous Gland Diseases
- Acne Vulgaris
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Estrogens
- Anti-Bacterial Agents
- Hormone Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral, Combined
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Androgen Antagonists
- Contraceptive Agents, Male
- Moxifloxacin
- Norgestimate, ethinyl estradiol drug combination
- Estradiol
- Ethinyl Estradiol
- Estradiol 17 beta-cypionate
- Estradiol 3-benzoate
- Polyestradiol phosphate
- Cyproterone Acetate
- Cyproterone
- Norgestimate
Other Study ID Numbers
- CR007129
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acne Vulgaris
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Assiut UniversityCompleted
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Clinical Trials on Norgestimate-ethinyl estradiol; Cyproterone acetate-ethinyl estradiol
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Janssen-Cilag Ltd.,ThailandCompleted
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University of VermontUniversity of Vermont Medical CenterCompletedVenous Thrombosis
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University of PennsylvaniaSociety of Family PlanningTerminatedCystic Fibrosis Exacerbations While on and Off Hormonal ContraceptionUnited States