Acne VulgarisPhase 3NCT00280657
Study on Safety and Efficacy of an Oral Contraceptive in Treating Acne Papulopustulosa
A Phase 3 study testing Valette and Diane in people with Acne Vulgaris, run by Bayer at 62 sites in 5 countries.
Trial summary
The purpose of the study is to determine safety and efficacy of an oral contraceptive in treating acne papulopustulosa. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Valette and Diane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,326 participants
- Where
- 62 sitesin 5 countries
- Study dates
- 10 Mar 2004to 21 May 2005
- Phase
- Phase 3
- 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 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with mild to moderate facial papulopustular acne
Who cannot join
- Contraindication against use of hormonal contraceptives
Trial locations and contacts
62 sites in 5 countries.
62 sites in 5 countries
Russia19 sites
Study site
Korolyov, 141074
Study site
Moscow, 109004
Study site
Moscow, 121614
Study site
Moscow, 123182
Study site
Moscow, 123423
Study site
Moscow, 125009
Study site
Moscow, 125047
Study site
Moskva, 107076
Study site
Moskva, 121002
Study site
Petrozavodsk, 185910
Study site
Saint Petersburg, 190020
Study site
Saint Petersburg, 192012
Study site
Saint Petersburg, 192102
Study site
Saint Petersburg, 194 291
Study site
Saint Petersburg, 194044
Study site
Saint Petersburg, 194175
Study site
Saint Petersburg, 195067
Study site
Saint Petersburg, 197183
Study site
Saint Petersburg, 197198
Ukraine19 sites
Study site
Alchevs'k, 94201
Study site
Chernivtsi, 58000
Study site
Dnipropetrovsk, 49076
Study site
Donetsk, 83087
Study site
Ivano-Frankivsk, 76000
Study site
Kharkiv, 61057
Study site
Kiev, 01032
Study site
Kiev, 03035
Study site
Kyiv, 01021
Study site
Luhansk, 91017
Study site
Lviv, 81130
Study site
Makiyivka, 86106
Study site
Odesa, 65006
Study site
Poltava, 314039
Study site
Rivne, 33028
Study site
Simferopol, 95006
Study site
Ternopil, 46006
Study site
Uzhhorod, 88011
Study site
Zaporizhzhya, 69063
Czechia10 sites
Study site
Čáslav, 28601
Study site
Chomutov, 43012
Study site
Kutná Hora, 28401
Study site
Louny, 44001
Study site
Olomouc, 77900
Study site
Prague, 10034
Study site
Prague, 15500
Study site
Slaný, 274 01
Study site
Svitavy, 56802
Study site
Ústí nad Labem, 40010
Poland9 sites
Study site
Grudziądz, 86-300
Study site
Lodz, 90265
Study site
Lublin, 20319
Study site
Poznan, 60631
Study site
Warsaw, 00710
Study site
Warsaw, 01456
Study site
Warsaw, 01684
Study site
Warsaw, 02722
Study site
Wroclaw, 50-353
Slovakia5 sites
Study site
Banská Bystrica, 97401
Study site
Bratislava, 83331
Study site
Košice, 04066
Study site
Kosice-Saca, 04015
Study site
Nitra, 94901
About this study
Official title: Multicenter, Double-blind, Double-dummy, Randomized Parallel Group Study to Evaluate the Safety and Efficacy of SH D 00659 E for 6 Treatment Cycles in Female Patients With Acne Papulopustulosa in Comparison to SH D 00659 G and Placebo.
The purpose of the study is to determine safety and efficacy of an oral contraceptive in treating acne papulopustulosa.
Read the detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
- Conditions
- Acne Vulgaris
- Being tested
- Valette, Diane, Placebo
- Keywords
- Acne papulopustulosa
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValetteDrug
1 tablet 0.030 mg ethinylestradiol / 2 mg dienogest + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles
DianeDrug
1 tablet 0.035 mg ethinylestradiol / 2 mg cyproterone acetate + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles
PlaceboDrug
2 placebo tablets daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Valette |
| Arm 2 | Active comparator | Not described Receives: Drug: Diane |
| Arm 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lesions
Measured: 6 months
Secondary outcomes (2)
ISGA
Measured: 6 months
Parameters of safety and tolerability
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2006 (estimated)
- Study start10 Mar 2004
- Primary completion21 May 2005
- Study completion21 May 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.
- More trials run by BayerThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280657
- Sponsor's protocol ID
- 91299
- Other IDs
- 307760
- Status last verified
- Jun 2023
- First submitted
- 20 Jan 2006
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double-blind, Double-dummy, Randomized Parallel Group Study to Evaluate the Safety and Efficacy of SH D 00659 E for 6 Treatment Cycles in Female Patients With Acne Papulopustulosa in Comparison to SH D 00659 G and Placebo.
- ClinicalTrials.gov ID
- NCT00280657
- Acronym / sponsor ID
- 91299
- Conditions
- Acne Vulgaris
- Keywords
- Acne papulopustulosa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,326 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2004 (actual)
- Primary completion
- 21 May 2005 (actual)
- Study completion
- 21 May 2005 (actual)
- First posted
- 23 Jan 2006 (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 the study is to determine safety and efficacy of an oral contraceptive in treating acne papulopustulosa.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Valette |
| Arm 2 | Active comparator | Drug: Diane |
| Arm 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with mild to moderate facial papulopustular acne
Key exclusion criteria (1 listed)
- Contraindication against use of hormonal contraceptives
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 |
|---|---|---|
| Valette1 tablet 0.030 mg ethinylestradiol / 2 mg dienogest + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles | Drug | Arm 1 |
| Diane1 tablet 0.035 mg ethinylestradiol / 2 mg cyproterone acetate + 1 placebo tablet daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles | Drug | Arm 2 |
| Placebo2 placebo tablets daily for 21 days followed by a 7-day tablet-free interval, oral administration for 6 cycles | Drug | Arm 3 |
Primary outcome
Change in lesions
Time frame: 6 months
2 secondary outcomes
ISGA
Time frame: 6 months
Parameters of safety and tolerability
Time frame: 6 months
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 6 Jun 2023.
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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.
Bayer Study Director study director
Bayer
62 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Valette and Diane in people with Acne Vulgaris, run by Bayer at 62 sites in 5 countries.
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 1 inclusion and 1 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 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in Russia, Ukraine, Czechia, Poland, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in lesions (time frame: 6 months). 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 6 Jun 2023.