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
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
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- 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