Papulopustular RosaceaPhase 4NCT01872715
Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea
A Phase 4 study testing Oracea in people with Papulopustular Rosacea, run by Galderma R&D at 1 site in United States.
Trial summary
The purpose of this study is to characterize rosacea patients', being treated with Oracea, perception through visual analog scale reporting. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Papulopustular Rosacea
- What is being tested?
- Oracea
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jun 2013
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women
- 25-70 years
- Diagnosis of papulopustular rosacea
- Eligible for Oracea treatment
Who cannot join
- Allergies to components of investigational product and/or hypersensitivity to tetracyclines
- Taken systemic therapy directed at improving rosacea, including antibiotics, within 30 days prior to baseline visit
- Used topical rosacea treatment within 30 days prior to baseline visit
- Have active ocular rosacea and/or blepharitis/meibomianitis requiring systemic treatment by an opthalmologist
- Previously failed to have improvement of rosacea with appropriate use of systemic tetracycline family of antibiotics
- Exposed to intense/excessive ultraviolet (UV) radiation within one week prior to baseline and/or who forsee unprotected and intense/excessive UV exposure during the course of the study
Show all 9Show fewer
- Have planned surgical procedures during the course of the study
- Have used tetracycline antibiotics within 30 days prior to baseline visit or during study
- At risk in terms of precautions, warnings, and contraindications
Trial locations and contacts
1 site in 1 country.
United States1 site
Stephens & Associates Dallas Research Center
Carrollton, Texas, 75006
About this study
The purpose of this study is to characterize rosacea patients', being treated with Oracea, perception through visual analog scale reporting.
- Conditions
- Papulopustular Rosacea
- Being tested
- Oracea
- Keywords
- Papulopustular Rosacea, Oracea, anti inflammatory doxycycline
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OraceaDrug
Also called doxycycline USP, 40 mg (30 mg immediate release/ 10 mg delayed release beads)
| Study group | Role | What they receive |
|---|---|---|
| Oracea | Experimental | Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.
Oral dose for 12 weeks Receives: Drug: Oracea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rosacea Score on the Visual Analog Scale
VAS = visual analog scale, 10 cm scale in which 0 = no rosacea, 10 = worst rosacea imaginable
Measured: Baseline, Weeks 2, 6, and 12
Secondary outcomes (3)
Rosacea-Specific Quality of Life Index
ROSACEA-SPECIFIC QUALITY OF LIFE INDEX©: average of scores to 22 questions on a 5 point scale (1 = never, 5 = all the time)
Measured: Baseline, Weeks 2, 6, and 12
Patient Global Assessment (PGA) of Rosacea Scores
Patient Global Assessment (PGA) of Rosacea: 0 = clear, no signs or symptoms present; 1 = Near clear, 1 or 2 papules; 2 = mild, some (3 to 10) papules/pustules; 3 = moderate, moderate (11 to 19) number of papules and pustules; 4 = severe, numerous (≥ 20) papules/pustules; nodules
Measured: Baseline, Weeks 2, 6, and 12
Patient Satisfaction Question
The patient satisfaction question was answered by the subject at week 2, week 6, and week 12. The subject was asked how satisfied they were with this treatment (doxycycline MR) for rosacea.
Measured: Week 2, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionJun 2013
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 Papulopustular RosaceaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872715
- Sponsor's protocol ID
- GLI.04.SPR.US10233
- Status last verified
- Jan 2016
- First submitted
- 15 Mar 2013
- Last updated
- 23 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 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea
- ClinicalTrials.gov ID
- NCT01872715
- Acronym / sponsor ID
- GLI.04.SPR.US10233
- Conditions
- Papulopustular Rosacea
- Keywords
- Papulopustular Rosacea, Oracea, anti inflammatory doxycycline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Posted 15 Feb 2016
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 is to characterize rosacea patients', being treated with Oracea, perception through visual analog scale reporting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oracea | Experimental | Drug: OraceaOracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after. Oral dose for 12 weeks |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women
- 25-70 years
- Diagnosis of papulopustular rosacea
- Eligible for Oracea treatment
Key exclusion criteria (9 listed)
- Allergies to components of investigational product and/or hypersensitivity to tetracyclines
- Taken systemic therapy directed at improving rosacea, including antibiotics, within 30 days prior to baseline visit
- Used topical rosacea treatment within 30 days prior to baseline visit
- Have active ocular rosacea and/or blepharitis/meibomianitis requiring systemic treatment by an opthalmologist
- Previously failed to have improvement of rosacea with appropriate use of systemic tetracycline family of antibiotics
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 |
|---|---|---|
| OraceaAlso: doxycycline USP, 40 mg (30 mg immediate release/ 10 mg delayed release beads) | Drug | Oracea |
Primary outcome
Rosacea Score on the Visual Analog Scale
Time frame: Baseline, Weeks 2, 6, and 12
VAS = visual analog scale, 10 cm scale in which 0 = no rosacea, 10 = worst rosacea imaginable
3 secondary outcomes
Rosacea-Specific Quality of Life Index
Time frame: Baseline, Weeks 2, 6, and 12
Patient Global Assessment (PGA) of Rosacea Scores
Time frame: Baseline, Weeks 2, 6, and 12
Patient Satisfaction Question
Time frame: Week 2, 6, and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Oracea in people with Papulopustular 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 4 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 23 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 15 Feb 2016). 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?
Rosacea Score on the Visual Analog Scale (time frame: Baseline, Weeks 2, 6, and 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 23 Aug 2022.