Papulopustular Rosacea
Conditions
Keywords
Papulopustular Rosacea, Oracea, anti inflammatory doxycycline
Brief summary
The purpose of this study is to characterize rosacea patients', being treated with Oracea, perception through visual analog scale reporting.
Interventions
DRUGOracea
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Men and women * 25-70 years * Diagnosis of papulopustular rosacea * Eligible for Oracea treatment
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rosacea Score on the Visual Analog Scale | Baseline, Weeks 2, 6, and 12 | VAS = visual analog scale, 10 cm scale in which 0 = no rosacea, 10 = worst rosacea imaginable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rosacea-Specific Quality of Life Index | Baseline, Weeks 2, 6, and 12 | ROSACEA-SPECIFIC QUALITY OF LIFE INDEX©: average of scores to 22 questions on a 5 point scale (1 = never, 5 = all the time) |
| Patient Global Assessment (PGA) of Rosacea Scores | Baseline, Weeks 2, 6, and 12 | 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 |
| Patient Satisfaction Question | Week 2, 6, and 12 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oracea 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
Oracea | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Oracea |
|---|---|
| Age, Continuous | 53.04 years STANDARD_DEVIATION 11.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fistzpatrick Skin Type I | 2 participants |
| Fistzpatrick Skin Type II | 15 participants |
| Fistzpatrick Skin Type III | 5 participants |
| Fistzpatrick Skin Type IV | 2 participants |
| Fistzpatrick Skin Type V | 0 participants |
| Fistzpatrick Skin Type VI | 0 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 23 Participants |
| Skin type Combination | 11 participants |
| Skin type Dry | 8 participants |
| Skin type Normal | 4 participants |
| Skin type Oily | 1 participants |
| Years since the first rosacea diagnosis | 5.75 years STANDARD_DEVIATION 8.36 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Rosacea Score on the Visual Analog Scale
VAS = visual analog scale, 10 cm scale in which 0 = no rosacea, 10 = worst rosacea imaginable
Time frame: Baseline, Weeks 2, 6, and 12
Population: Intent-to-Treat (ITT) population: All subjects who were enrolled and had at least 1 posttreatment administration evaluation. This is the primary population for efficacy analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oracea | Rosacea Score on the Visual Analog Scale | Baseline | 4.50 units on a scale | Standard Deviation 1.81 |
| Oracea | Rosacea Score on the Visual Analog Scale | Week 2 | 4.52 units on a scale | Standard Deviation 1.87 |
| Oracea | Rosacea Score on the Visual Analog Scale | Week 6 | 3.77 units on a scale | Standard Deviation 1.93 |
| Oracea | Rosacea Score on the Visual Analog Scale | Week 12 | 3.06 units on a scale | Standard Deviation 2.34 |
Secondary
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
Time frame: Baseline, Weeks 2, 6, and 12
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oracea | Patient Global Assessment (PGA) of Rosacea Scores | Baseline | 0 participants |
| Oracea | Patient Global Assessment (PGA) of Rosacea Scores | Week 2 | 0 participants |
| Oracea | Patient Global Assessment (PGA) of Rosacea Scores | Week 6 | 0 participants |
| Oracea | Patient Global Assessment (PGA) of Rosacea Scores | Week 12 | 3 participants |
| 1 = Near Clear | Patient Global Assessment (PGA) of Rosacea Scores | Baseline | 1 participants |
| 1 = Near Clear | Patient Global Assessment (PGA) of Rosacea Scores | Week 12 | 14 participants |
| 1 = Near Clear | Patient Global Assessment (PGA) of Rosacea Scores | Week 2 | 4 participants |
| 1 = Near Clear | Patient Global Assessment (PGA) of Rosacea Scores | Week 6 | 10 participants |
| 2 = Mild | Patient Global Assessment (PGA) of Rosacea Scores | Week 12 | 4 participants |
| 2 = Mild | Patient Global Assessment (PGA) of Rosacea Scores | Week 2 | 16 participants |
| 2 = Mild | Patient Global Assessment (PGA) of Rosacea Scores | Week 6 | 11 participants |
| 2 = Mild | Patient Global Assessment (PGA) of Rosacea Scores | Baseline | 17 participants |
| 3 = Moderate | Patient Global Assessment (PGA) of Rosacea Scores | Baseline | 4 participants |
| 3 = Moderate | Patient Global Assessment (PGA) of Rosacea Scores | Week 2 | 2 participants |
| 3 = Moderate | Patient Global Assessment (PGA) of Rosacea Scores | Week 12 | 1 participants |
| 3 = Moderate | Patient Global Assessment (PGA) of Rosacea Scores | Week 6 | 1 participants |
| 4 = Severe | Patient Global Assessment (PGA) of Rosacea Scores | Week 12 | 0 participants |
| 4 = Severe | Patient Global Assessment (PGA) of Rosacea Scores | Week 6 | 0 participants |
| 4 = Severe | Patient Global Assessment (PGA) of Rosacea Scores | Week 2 | 0 participants |
| 4 = Severe | Patient Global Assessment (PGA) of Rosacea Scores | Baseline | 0 participants |
Secondary
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.
Time frame: Week 2, 6, and 12
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oracea | Patient Satisfaction Question | Week 2 | 1 participants |
| Oracea | Patient Satisfaction Question | Week 12 | 8 participants |
| Oracea | Patient Satisfaction Question | Week 6 | 4 participants |
| 1 = Near Clear | Patient Satisfaction Question | Week 6 | 7 participants |
| 1 = Near Clear | Patient Satisfaction Question | Week 2 | 11 participants |
| 1 = Near Clear | Patient Satisfaction Question | Week 12 | 6 participants |
| 2 = Mild | Patient Satisfaction Question | Week 6 | 8 participants |
| 2 = Mild | Patient Satisfaction Question | Week 2 | 8 participants |
| 2 = Mild | Patient Satisfaction Question | Week 12 | 5 participants |
| 3 = Moderate | Patient Satisfaction Question | Week 2 | 2 participants |
| 3 = Moderate | Patient Satisfaction Question | Week 12 | 2 participants |
| 3 = Moderate | Patient Satisfaction Question | Week 6 | 2 participants |
| 4 = Severe | Patient Satisfaction Question | Week 6 | 1 participants |
| 4 = Severe | Patient Satisfaction Question | Week 2 | 0 participants |
| 4 = Severe | Patient Satisfaction Question | Week 12 | 1 participants |
Secondary
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)
Time frame: Baseline, Weeks 2, 6, and 12
Population: Intent-to-Treat (ITT) population: All subjects who were enrolled and had at least 1 posttreatment administration evaluation. This is the primary population for efficacy analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oracea | Rosacea-Specific Quality of Life Index | Baseline | 3.34 units on a scale | Standard Deviation 0.55 |
| Oracea | Rosacea-Specific Quality of Life Index | Week 2 | 3.07 units on a scale | Standard Deviation 0.56 |
| Oracea | Rosacea-Specific Quality of Life Index | Week 6 | 2.89 units on a scale | Standard Deviation 0.81 |
| Oracea | Rosacea-Specific Quality of Life Index | Week 12 | 2.85 units on a scale | Standard Deviation 0.86 |