NCT00752635

CompletedPhase 4

Comparison of Efficacy and Safety of Norgestimate-ethinyl Es...

Johnson & Johnson Taiwan Ltd Source

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Other study identifiers

Sponsor study identifier

CR007129

Study Type

interventional

Actual enrollment (reported)

48

Locations

0 countries

Sites

N/A

Timeline

Study Start

September 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

September 2005

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 48 participants
Study completion date: September 2005
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2004
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
September 2005
Actual (reported)
First Submitted
September 11, 2008
Actual (reported)
First Posted
September 15, 2008
Actual (reported)

Last Updated: May 19, 2011
Status Verified: April 2010
Last Update Submitted: May 18, 2011

Conditions

Acne Vulgaris

Keywords

TriCilestacne 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 estradiolDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age15 Years - 49 Years

Sexfemale

Healthy VolunteersNo

Age GroupsChild (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)

Sponsors & Collaborators

Johnson & Johnson Taiwan Ltd
Industrylead

MeSH Terms

Conditions

Acne Vulgaris

Interventions

MoxifloxacinCyproterone acetate, ethinyl estradiol drug combination

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-Ring

Study Officials

Johnson & Johnson Taiwan, Ltd. Clinical Trial
Johnson & Johnson Taiwan Ltd
STUDY DIRECTOR

Enrollment

48 participants (actual enrollment reported by the registry).

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 2004

Date type not reported

This date has not been verified as actual or estimated.

NCT00377000

A Pilot, Multi-Center, Patient Preference Study Comparing Two Clindamycin/Benzoyl Peroxide Gels.

Phase 4Completed

NCT00658112

Measuring Adherence in Subjects With Acne Vulgaris in a Clinic Population Subtitle: Topical Benzoyl Peroxide for Acne

Phase 4Completed

NCT04490967

Silymarin Cream Versus Salicylic Acid in Treatment of Acne Vulgaris

Phase 4Unknown

NCT00696449

Analysis of Adherence in Subjects Undergoing Differin Gel, 0.1% Treatment of Moderate to Severe Acne Vulgaris

Phase 4Completed

NCT00243542

Phase IV Study to Gather More Information About the Safety of ACZONE Gel, 5% in Treating Subjects With Acne Who Have G6PD Deficiency

Phase 4Completed

NCT07392047

Metronidazole 2% Gel Versus Clindamycin 1% Gel for Moderate Acne Vulgaris

Phase 4Not Yet Recruiting

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)

Contact the study team to confirm eligibility.

Heterocyclic Compounds, Fused-Ring

Heterocyclic Compounds

Study Completion

September 2005

Actual (reported)

Last Updated

May 19, 2011

Record last verified: 2010-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00752635
Data provider: ClinicalTrials.gov
Source updated: 2011-05-19
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:39 UTC

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record