Rosacea
Conditions
Brief 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.
Interventions
DRUGdoxycycline (Oracea®) 40 mg modified release as monotherapy
Take once daily in the morning
DRUGdoxycycline (Oracea®) 40 mg modified release as add-on therapy
Take once daily in the morning
Sponsors
Galderma R&D
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females aged 18 and older * Subjects with diagnosis of rosacea (IGA of 2 to 4)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | Baaseline to Week 12 | 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. |
| Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear) | Baseline to Week 12 | 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. |
Countries
United States
Participant flow
Recruitment details
Dates of recruitment period: First subject was enrolled on April 30, 2009 and the last subject enrolled was on July 31, 2009. Types of location: Investigative sites were located at academic institutions and private physician offices.
Pre-assignment details
The wash-out period up to baseline was 4 months (systemic acne treatment); 4 wks (antibiotics); 3 months \[intense pulsed light(IPL) treatment\]. Subjects were assigned to the Oracea® as Monotherapy (Oracea® alone) or Oracea® as Add-on Therapy groups (Oracea®/Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides).
Participants by arm
| Arm | Count |
|---|---|
| Oracea® as Monotherapy Oracea® 40 mg per day as monotherapy. | 1,197 |
| Oracea® as add-on Therapy Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert. | 224 |
| Total | 1,421 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 65 | 8 |
| Overall Study | Bad taste in mouth after taking Oracea® | 0 | 1 |
| Overall Study | Death in family | 1 | 0 |
| Overall Study | Did not meet incl/excl criteria | 1 | 0 |
| Overall Study | Family emergency | 1 | 0 |
| Overall Study | Final visit completed 4 weeks late | 0 | 1 |
| Overall Study | Lack of efficacy of study product | 2 | 0 |
| Overall Study | Last visit not done - death in family | 1 | 0 |
| Overall Study | Lost to Follow-up | 81 | 8 |
| Overall Study | Missed multiple visits | 1 | 0 |
| Overall Study | Missed Visit 4 and off meds for 65 days | 1 | 1 |
| Overall Study | Missed visits rescheduled out of window | 1 | 0 |
| Overall Study | Non-compliant with visits as scheduled | 1 | 0 |
| Overall Study | No show Visit 2; prescription not filled | 1 | 0 |
| Overall Study | PI complained of inadequate compensation | 3 | 0 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Protocol Violation | 7 | 2 |
| Overall Study | Rash on hand | 1 | 0 |
| Overall Study | Rosacea cleared; subject D/C'd self | 1 | 0 |
| Overall Study | Scheduled for knee replacement | 0 | 1 |
| Overall Study | Subject completed day after study closed | 1 | 0 |
| Overall Study | Subject did not return for any visits | 1 | 0 |
| Overall Study | Subject failed to return for final visit | 2 | 0 |
| Overall Study | Subject had history of drug abuse | 1 | 0 |
| Overall Study | Subject lost interest in program | 0 | 1 |
| Overall Study | Subject missed several visits/lost meds | 1 | 0 |
| Overall Study | Subject not good candidate for study | 1 | 0 |
| Overall Study | Subject not seen by PI at final visit | 1 | 0 |
| Overall Study | Subject unable to keep follow-up visits | 1 | 0 |
| Overall Study | Unable to redeem the drug voucher | 1 | 0 |
| Overall Study | Visit 4 date out of window | 1 | 0 |
| Overall Study | Withdrawal by Subject | 86 | 14 |
Baseline characteristics
| Characteristic | Oracea® as Monotherapy | Oracea® as add-on Therapy | Total |
|---|---|---|---|
| Age, Continuous >=18 years | 50.2 years STANDARD_DEVIATION 13.9 | 53.4 years STANDARD_DEVIATION 12.9 | 50.7 years STANDARD_DEVIATION 13.4 |
| Sex: Female, Male Female | 853 Participants | 154 Participants | 1007 Participants |
| Sex: Female, Male Male | 344 Participants | 70 Participants | 414 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1,196 | 0 / 224 |
| serious Total, serious adverse events | 5 / 1,196 | 0 / 224 |
Outcome results
Primary
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.
Time frame: Baseline to Week 12
Population: Per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oracea® as Monotherapy | Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | +3 (worsening of rosacea by 3 IGA scale levels) | 0 participants |
| Oracea® as Monotherapy | Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | -1 (improvement of rosacea by 1 IGA scale level | 254 participants |
| Oracea® as Monotherapy | Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | +1 (worsening of rosacea by 1 IGA scale level) | 4 participants |
| Oracea® as Monotherapy | Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | -2 (improvement of rosacea by 2 IGA scale levels) | 365 participants |
| Oracea® as Monotherapy | Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | +2 (worsening of rosacea by 2 IGA scale levels) | 0 participants |
| Oracea® as Monotherapy | Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | -3 (improvement of rosacea by 3 IGA scale levels) | 123 participants |
| Oracea® as Monotherapy | Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | 0 (no change in IGA scale level) | 70 participants |
| Oracea® as Monotherapy | Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | -4 (improvement of rosacea by 4 IGA scale levels) | 10 participants |
| Oracea® as Monotherapy | Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | +4 (worsening of rosacea by 4 IGA scale levels | 0 participants |
| Oracea® as add-on Therapy | Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | -4 (improvement of rosacea by 4 IGA scale levels) | 4 participants |
| Oracea® as add-on Therapy | Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | +4 (worsening of rosacea by 4 IGA scale levels | 0 participants |
| Oracea® as add-on Therapy | Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | +3 (worsening of rosacea by 3 IGA scale levels) | 0 participants |
| Oracea® as add-on Therapy | Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | +2 (worsening of rosacea by 2 IGA scale levels) | 0 participants |
| Oracea® as add-on Therapy | Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | +1 (worsening of rosacea by 1 IGA scale level) | 4 participants |
| Oracea® as add-on Therapy | Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | 0 (no change in IGA scale level) | 11 participants |
| Oracea® as add-on Therapy | Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | -1 (improvement of rosacea by 1 IGA scale level | 42 participants |
| Oracea® as add-on Therapy | Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | -2 (improvement of rosacea by 2 IGA scale levels) | 65 participants |
| Oracea® as add-on Therapy | Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | -3 (improvement of rosacea by 3 IGA scale levels) | 14 participants |
Secondary
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.
Time frame: Baaseline to Week 12
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oracea® as Monotherapy | Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | +3 (worsening of erythema by 3 CEA scale levels) | 0 participants |
| Oracea® as Monotherapy | Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | -1 (improvement in erythema by 1 CEA scale level) | 415 participants |
| Oracea® as Monotherapy | Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | +1 (worsening of erythema by 1 CEA scale level) | 6 participants |
| Oracea® as Monotherapy | Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | -2 (improvement in erythema by 2 CEA scale levels) | 261 participants |
| Oracea® as Monotherapy | Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | +2 (worsening of erythema by 2 CEA scale levels) | 0 participants |
| Oracea® as Monotherapy | Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | -3 (improvement in erythema by 3 CEA scale levels) | 45 participants |
| Oracea® as Monotherapy | Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | 0 (no change in CEA scale level) | 97 participants |
| Oracea® as Monotherapy | Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | -4 (improvement of erythema by 4 CEA scale levels) | 2 participants |
| Oracea® as Monotherapy | Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | +4 (worsening of erythema by 4 CEA scale levels) | 0 participants |
| Oracea® as add-on Therapy | Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | -4 (improvement of erythema by 4 CEA scale levels) | 0 participants |
| Oracea® as add-on Therapy | Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | +4 (worsening of erythema by 4 CEA scale levels) | 0 participants |
| Oracea® as add-on Therapy | Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | +3 (worsening of erythema by 3 CEA scale levels) | 0 participants |
| Oracea® as add-on Therapy | Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | +2 (worsening of erythema by 2 CEA scale levels) | 0 participants |
| Oracea® as add-on Therapy | Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | +1 (worsening of erythema by 1 CEA scale level) | 2 participants |
| Oracea® as add-on Therapy | Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | 0 (no change in CEA scale level) | 18 participants |
| Oracea® as add-on Therapy | Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | -1 (improvement in erythema by 1 CEA scale level) | 76 participants |
| Oracea® as add-on Therapy | Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | -2 (improvement in erythema by 2 CEA scale levels) | 38 participants |
| Oracea® as add-on Therapy | Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | -3 (improvement in erythema by 3 CEA scale levels) | 6 participants |
Secondary
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.
Time frame: Baseline to Week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oracea® as Monotherapy | Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear) | 616 participants |
| Oracea® as add-on Therapy | Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear) | 106 participants |