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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oracea® as monotherapy | Other | Oracea as monotherapy |
|
| Oracea® as add-on therapy | Other | Oracea® as add-on Therapy (Oracea® + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doxycycline (Oracea®) 40 mg modified release as monotherapy | Drug | Take once daily in the morning |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald W Gottschalk, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| REGISTRAT® - MAP1, Inc. (CRO) | Lexington | Kentucky | 40504-3276 | United States |
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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oracea® as Monotherapy | Oracea® 40 mg per day as monotherapy. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oracea® as Monotherapy | Oracea® 40 mg per day as monotherapy. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per protocol | Posted | Number | participants | Baseline to Week 12 |
|
12 weeks
Subjects were asked if there had been any change in their health at each study visit; information obtained was recorded as adverse event(s), if applicable.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oracea® as Monotherapy | Oracea® 40 mg per day as monotherapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald W. Gottschalk, MD / Medical Director | Galderma Laboratories, L.P. | 817-961-5358 | ron.gottschalk@galderma.com |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| doxycycline (Oracea®) 40 mg modified release as add-on therapy | Drug | Take once daily in the morning |
|
|
| 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. | Baseline to Week 12 |
| Pregnancy |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Subject failed to return for final visit |
|
| Subject unable to keep follow-up visits |
|
| Final visit completed 4 weeks late |
|
| Subject completed day after study closed |
|
| Family emergency |
|
| Last visit not done - death in family |
|
| Did not meet incl/excl criteria |
|
| Rosacea cleared; subject D/C'd self |
|
| Unable to redeem the drug voucher |
|
| Subject not good candidate for study |
|
| Subject did not return for any visits |
|
| Subject missed several visits/lost meds |
|
| Missed Visit 4 and off meds for 65 days |
|
| Scheduled for knee replacement |
|
| PI complained of inadequate compensation |
|
| Subject lost interest in program |
|
| Bad taste in mouth after taking Oracea® |
|
| Death in family |
|
| Lack of efficacy of study product |
|
| Subject not seen by PI at final visit |
|
| No show Visit 2; prescription not filled |
|
| Missed multiple visits |
|
| Missed visits rescheduled out of window |
|
| Non-compliant with visits as scheduled |
|
| Subject had history of drug abuse |
|
| Rash on hand |
|
| Visit 4 date out of window |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | 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. | Posted | Number | participants | Baaseline to Week 12 |
|
|
|
| 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. | Posted | Number | participants | Baseline to Week 12 |
|
|
|
| 5 |
| 1,196 |
| 0 |
| 1,196 |
| EG001 | 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. | 0 | 224 | 0 | 224 |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Thrombophlebitis superficial | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
|
The principal investigator has the right to publish or present the data resulting from this study, with agreed upon reviews by all interested parties, and in accordance with any confidentiality agreements that may exist.
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| +2 (worsening of erythema by 2 CEA scale levels) |
|
| +1 (worsening of erythema by 1 CEA scale level) |
|
| 0 (no change in CEA scale level) |
|
| -1 (improvement in erythema by 1 CEA scale level) |
|
| -2 (improvement in erythema by 2 CEA scale levels) |
|
| -3 (improvement in erythema by 3 CEA scale levels) |
|
| -4 (improvement of erythema by 4 CEA scale levels) |
|