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Comparison of Efficacy and Safety of Norgestimate-Ethinyl Estradiol and Cyproterone Acetate-Ethinyl Estradiol in the Treatment of Acne Vulgaris
This study has been completed.
First Received: September 11, 2008   Last Updated: November 20, 2008   History of Changes
Sponsored by: Johnson & Johnson Taiwan Ltd
Information provided by: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier: NCT00752635
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
Drug: Norgestimate-ethinyl estradiol; Cyproterone acetate-ethinyl estradiol
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Taiwan Ltd:

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.

Enrollment: 48
Study Start Date: September 2004
Study Completion Date: September 2005
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.

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752635

Sponsors and Collaborators
Johnson & Johnson Taiwan Ltd
Investigators
Study Director: Johnson & Johnson Taiwan, Ltd. Clinical Trial Johnson & Johnson Taiwan Ltd
  More Information

Additional Information:
No publications provided

Study ID Numbers: CR007129
Study First Received: September 11, 2008
Last Updated: November 20, 2008
ClinicalTrials.gov Identifier: NCT00752635     History of Changes
Health Authority: Taiwan: Department of Health

Keywords provided by Johnson & Johnson Taiwan Ltd:
TriCilest
acne vulgaris

Study placed in the following topic categories:
Anti-Infective Agents
Facial Dermatoses
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Estradiol valerate
Contraceptive Agents, Female
Cyproterone
Hormones, Hormone Substitutes, and Hormone Antagonists
Estradiol 17 beta-cypionate
Sebaceous Gland Diseases
Contraceptive Agents, Male
Hormones
Acne Vulgaris
Exanthema
Moxifloxacin
Estradiol 3-benzoate
Polyestradiol phosphate
Diane
Estrogens
Facies
Skin Diseases
Benzoates
Cyproterone Acetate
Ethinyl Estradiol
Estradiol
Norgestimate
Androgen Antagonists
Androgens

Additional relevant MeSH terms:
Anti-Infective Agents
Facial Dermatoses
Antineoplastic Agents
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Estradiol valerate
Physiological Effects of Drugs
Contraceptive Agents, Female
Cyproterone
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Estradiol 17 beta-cypionate
Sebaceous Gland Diseases
Contraceptive Agents, Male
Hormones
Acne Vulgaris
Acneiform Eruptions
Moxifloxacin
Estradiol 3-benzoate
Therapeutic Uses
Contraceptives, Oral, Synthetic
Diane
Polyestradiol phosphate
Estrogens
Skin Diseases
Cyproterone Acetate
Ethinyl Estradiol
Estradiol
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 02, 2009