RosaceaPhase 4NCT00892281
ORCA - Oracea® for Rosacea: A Community-based Assessment
A Phase 4 study testing doxycycline (Oracea®) 40 mg modified release as monotherapy and doxycycline (Oracea®) 40 mg modified release as add-on therapy in people with Rosacea, run by Galderma R&D at 1 site in United States.
Trial summary
The objective of this study is to assess the effectiveness, safety, subject satisfaction and quality of life with Oracea® when used as monotherapy or as add-on therapy to existing topical regimens for the treatment of rosacea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea
- What is being tested?
- doxycycline (Oracea®) 40 mg modified release as monotherapy and doxycycline (Oracea®) 40 mg modified release as add-on therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,421 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Oct 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18 and older
- Subjects with diagnosis of rosacea (IGA of 2 to 4)
Who cannot join
- Subjects who used a topical or systemic acne treatment within 4 months of the baseline visit (retinoids and isotretinoin)
- Subjects who used a topical or systemic antibiotic within 4 weeks of the baseline visit
- Subjects who had laser or IPL (intense pulsed light) treatments within 3 months of the baseline visit and/or who plan to have these treatments during the study
- Subjects who have a known hypersensitivity to tetracyclines or ingredients of the add on medications
- Subjects who have stomach or GI problems, kidney disease or have an active systemic fungal infection or a vaginal yeast infection are excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
REGISTRAT® - MAP1, Inc. (CRO)
Lexington, Kentucky, 40504-3276
About this study
Official title: A Phase 4, Open-Label, Multicenter, Community-based, 12-Week Trial Assessment of Effectiveness, Safety, and Subject Satisfaction With Oracea® [Doxycycline, USP] Capsules 40 mg (30 mg Immediate Release & 10 mg Delayed Release Beads) When Used as Monotherapy or as Add-On Therapy to Existing Topical Regimens for the Treatment of Rosacea
The objective of this study is to assess the effectiveness, safety, subject satisfaction and quality of life with Oracea® when used as monotherapy or as add-on therapy to existing topical regimens for the treatment of rosacea.
- Conditions
- Rosacea
- Being tested
- doxycycline (Oracea®) 40 mg modified release as monotherapy, doxycycline (Oracea®) 40 mg modified release as add-on therapy
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxycycline (Oracea®) 40 mg modified release as monotherapyDrug
Also called Oracea®
Take once daily in the morning
doxycycline (Oracea®) 40 mg modified release as add-on therapyDrug
Also called Oracea®
Take once daily in the morning
| Study group | Role | What they receive |
|---|---|---|
| Oracea® as monotherapy | Other | Oracea as monotherapy Receives: Drug: doxycycline (Oracea®) 40 mg modified release as monotherapy |
| Oracea® as add-on therapy | Other | Oracea® as add-on Therapy (Oracea® + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides Receives: Drug: doxycycline (Oracea®) 40 mg modified release as add-on therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint
Number of participants with a change (Week 12 minus Baseline) in Investigator's Global Assessment (IGA) score. IGA is measured on a scale from 0 - 4 with 0 = Clear; 1 = Near Clear; 2 = Mild; 3 = Moderate; and 4 = Severe. Results values (+4, +3, +2, +1, 0, -1, -2, -3, -4) represent change from Baseline to Week 12.
Measured: Baseline to Week 12
Secondary outcomes (2)
Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint
Number of participants with a change (Week 12 minus Baseline) in Clinician's Erythema Assessment Scale (CEA) score. Clinician's Erythema Assessment Scale (CEA) is a scale from 0 - 4 with 0 = None; 1 = Mild; 2 = Moderate; 3 = Significant; and 4 = Severe. Results values (+4, +3, +2, +1, 0, -1, -2, -3, -4) represent change from Baseline to Week 12 in CEA.
Measured: Baaseline to Week 12
Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear)
Number of treatment responders at week 12, where response is defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (near clear). IGA is measured on a scale from 0 - 4 with 0 = Clear, 1 = Near Clear; 2 = Mild; 3 = Moderate; and 4 = Severe with 0 being best and 4 being worst.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study startApr 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RosaceaStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,421 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald W Gottschalk, MD, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892281
- Sponsor's protocol ID
- US10120
- Status last verified
- Sep 2012
- First submitted
- 30 Apr 2009
- Last updated
- 25 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Open-Label, Multicenter, Community-based, 12-Week Trial Assessment of Effectiveness, Safety, and Subject Satisfaction With Oracea® [Doxycycline, USP] Capsules 40 mg (30 mg Immediate Release & 10 mg Delayed Release Beads) When Used as Monotherapy or as Add-On Therapy to Existing Topical Regimens for the Treatment of Rosacea
- ClinicalTrials.gov ID
- NCT00892281
- Acronym / sponsor ID
- US10120
- Conditions
- Rosacea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,421 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 4 May 2009 (estimated)
- Results
- Posted 18 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the effectiveness, safety, subject satisfaction and quality of life with Oracea® when used as monotherapy or as add-on therapy to existing topical regimens for the treatment of rosacea.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oracea® as monotherapy | Other | Drug: doxycycline (Oracea®) 40 mg modified release as monotherapyOracea as monotherapy |
| Oracea® as add-on therapy | Other | Drug: doxycycline (Oracea®) 40 mg modified release as add-on therapyOracea® as add-on Therapy (Oracea® + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females aged 18 and older
- Subjects with diagnosis of rosacea (IGA of 2 to 4)
Key exclusion criteria (5 listed)
- Subjects who used a topical or systemic acne treatment within 4 months of the baseline visit (retinoids and isotretinoin)
- Subjects who used a topical or systemic antibiotic within 4 weeks of the baseline visit
- Subjects who had laser or IPL (intense pulsed light) treatments within 3 months of the baseline visit and/or who plan to have these treatments during the study
- Subjects who have a known hypersensitivity to tetracyclines or ingredients of the add on medications
- Subjects who have stomach or GI problems, kidney disease or have an active systemic fungal infection or a vaginal yeast infection are excluded
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 |
|---|---|---|
| doxycycline (Oracea®) 40 mg modified release as monotherapyAlso: Oracea®Take once daily in the morning | Drug | Oracea® as monotherapy |
| doxycycline (Oracea®) 40 mg modified release as add-on therapyAlso: Oracea®Take once daily in the morning | Drug | Oracea® as add-on therapy |
Primary outcome
Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint
Time frame: Baseline to Week 12
Number of participants with a change (Week 12 minus Baseline) in Investigator's Global Assessment (IGA) score. IGA is measured on a scale from 0 - 4 with 0 = Clear; 1 = Near Clear; 2 = Mild; 3 = Moderate; and 4 = Severe. Results values (+4, +3, +2, +1, 0, -1, -2, -3, -4) represent change from Baseline to Week 12.
2 secondary outcomes
Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint
Time frame: Baaseline to Week 12
Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear)
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ronald W Gottschalk, MD study director
Galderma R&D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing doxycycline (Oracea®) 40 mg modified release as monotherapy and doxycycline (Oracea®) 40 mg modified release as add-on therapy in people with Rosacea, run by Galderma R&D at 1 site in United States.
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 2 inclusion and 5 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 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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?
Yes. Results are posted in the registry (first posted 18 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Investigator's Global Assessment (IGA) Score From Baseline to Endpoint (time frame: Baseline to Week 12). 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 25 Aug 2022.