Acne VulgarisPhase 4NCT00752635
Comparison of Efficacy and Safety of Norgestimate-ethinyl Estradiol and Cyproterone Acetate-ethinyl Estradiol in the Treatment of Acne Vulgaris
A Phase 4 study testing Norgestimate-ethinyl estradiol; Cyproterone acetate-ethinyl estradiol in people with Acne Vulgaris, run by Johnson & Johnson Taiwan Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Norgestimate-ethinyl estradiol; Cyproterone acetate-ethinyl estradiol
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Sep 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
About this 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
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.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- Norgestimate-ethinyl estradiol; Cyproterone acetate-ethinyl estradiol
- Keywords
- TriCilest, acne vulgaris
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norgestimate-ethinyl estradiol; Cyproterone acetate-ethinyl estradiolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startSep 2004
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Taiwan Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Taiwan, Ltd. Clinical Trial, Study director, Johnson & Johnson Taiwan Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752635
- Sponsor's protocol ID
- CR007129
- Status last verified
- Apr 2010
- First submitted
- 11 Sep 2008
- Last updated
- 19 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00752635
- Acronym / sponsor ID
- CR007129
- Conditions
- Acne Vulgaris
- Keywords
- TriCilest, acne vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Johnson & Johnson Taiwan LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Sep 2005 (actual)
- First posted
- 15 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Norgestimate-ethinyl estradiol; Cyproterone acetate-ethinyl estradiol | Drug | – |
Primary outcome
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.
1 secondary outcome
The secondary efficacy variable (change in lesion counts) showed consistent results to the primary efficacy endpoint.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
- Comparison of efficacy and safety of Tricilest (norgestimate-ethinyl estradiol) and Diane-35 (cyproterone acetate-ethinyl estradiol) in the treatment of acne vulgarisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Taiwan, Ltd. Clinical Trial study director
Johnson & Johnson Taiwan Ltd
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norgestimate-ethinyl estradiol; Cyproterone acetate-ethinyl estradiol in people with Acne Vulgaris, run by Johnson & Johnson Taiwan Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2011.