ORCA - Oracea® for Rosacea: A Community-based Assessment

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00892281
• Collaborator: (none)
• Enrollment: 1,421
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 236.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rosacea	Drug: doxycycline (Oracea®) 40 mg modified release as monotherapy; Drug: doxycycline (Oracea®) 40 mg modified release as add-on therapy	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 1421 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 4, Open-Label, Multicenter, Community-based, 12-Week Trial Assessment of Effectiveness, Safety, and Subject Satisfaction With Oracea® [Doxycycline, USP] Capsules 40 mg (30 mg Immediate Release & 10 mg Delayed Release Beads) When Used as Monotherapy or as Add-On Therapy to Existing Topical Regimens for the Treatment of Rosacea
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: Oracea® as monotherapy Oracea as monotherapy	Drug: doxycycline (Oracea®) 40 mg modified release as monotherapy; Take once daily in the morning; Other Names: Oracea®
Other: Oracea® as add-on therapy Oracea® as add-on Therapy (Oracea® + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides	Drug: doxycycline (Oracea®) 40 mg modified release as add-on therapy; Take once daily in the morning; Other Names: Oracea®

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	REGISTRAT® - MAP1, Inc. (CRO)	Lexington	Kentucky	United States	40504-3276

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Director: Ronald W Gottschalk, MD, Galderma R&D

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT00892281
• Other Study ID Numbers: US10120
• First Posted: May 4, 2009
• Last Update Posted: Oct 2, 2012
• Last Verified: Sep 1, 2012

• Additional relevant MeSH terms: Rosacea; Doxycycline

Study Results

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 Detail	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).

Arm/Group Title	Oracea® as Monotherapy	Oracea® as add-on Therapy
Arm/Group Description	Oracea® 40 mg per day as monotherapy.	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.
Period Title: Overall Study
STARTED	1197	224
COMPLETED	930	187
NOT COMPLETED	267	37

Baseline Characteristics

Arm/Group Title	Oracea® as Monotherapy	Oracea® as add-on Therapy	Total
Arm/Group Description	Oracea® 40 mg per day as monotherapy.	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.	Total of all reporting groups
Overall Participants	1197	224	1421
Age (years) [Mean (Standard Deviation) ]
>=18 years	50.2 (13.9)	53.4 (12.9)	50.7 (13.4)
Sex: Female, Male (Count of Participants)
Female	853 71.3%	154 68.8%	1007 70.9%
Male	344 28.7%	70 31.3%	414 29.1%

Outcome Measures

1. Primary Outcome

Title	Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint
Description	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

Outcome Measure Data

Analysis Population Description

Per protocol

Arm/Group Title	Oracea® as Monotherapy	Oracea® as add-on Therapy
Arm/Group Description	Oracea® 40 mg per day as monotherapy.	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.
Measure Participants	1197	224
+4 (worsening of rosacea by 4 IGA scale levels	0 0%	0 0%
+3 (worsening of rosacea by 3 IGA scale levels)	0 0%	0 0%
+2 (worsening of rosacea by 2 IGA scale levels)	0 0%	0 0%
+1 (worsening of rosacea by 1 IGA scale level)	4 0.3%	4 1.8%
0 (no change in IGA scale level)	70 5.8%	11 4.9%
-1 (improvement of rosacea by 1 IGA scale level	254 21.2%	42 18.8%
-2 (improvement of rosacea by 2 IGA scale levels)	365 30.5%	65 29%
-3 (improvement of rosacea by 3 IGA scale levels)	123 10.3%	14 6.3%
-4 (improvement of rosacea by 4 IGA scale levels)	10 0.8%	4 1.8%

2. Secondary Outcome

Title	Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oracea® as Monotherapy	Oracea® as add-on Therapy
Arm/Group Description	Oracea® 40 mg per day as monotherapy.	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.
Measure Participants	1197	224
+4 (worsening of erythema by 4 CEA scale levels)	0 0%	0 0%
+3 (worsening of erythema by 3 CEA scale levels)	0 0%	0 0%
+2 (worsening of erythema by 2 CEA scale levels)	0 0%	0 0%
+1 (worsening of erythema by 1 CEA scale level)	6 0.5%	2 0.9%
0 (no change in CEA scale level)	97 8.1%	18 8%
-1 (improvement in erythema by 1 CEA scale level)	415 34.7%	76 33.9%
-2 (improvement in erythema by 2 CEA scale levels)	261 21.8%	38 17%
-3 (improvement in erythema by 3 CEA scale levels)	45 3.8%	6 2.7%
-4 (improvement of erythema by 4 CEA scale levels)	2 0.2%	0 0%

3. Secondary Outcome

Title	Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oracea® as Monotherapy	Oracea® as add-on Therapy
Arm/Group Description	Oracea® 40 mg per day as monotherapy.	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.
Measure Participants	1197	224
Number [participants]	616 51.5%	106 47.3%

Adverse Events

Time Frame	12 weeks
Adverse Event Reporting Description	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.
Arm/Group Title	Oracea® as Monotherapy		Oracea® as add-on Therapy
Arm/Group Description	Oracea® 40 mg per day as monotherapy.		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.
All Cause Mortality
	Oracea® as Monotherapy		Oracea® as add-on Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Oracea® as Monotherapy		Oracea® as add-on Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/1196 (0.4%)		0/224 (0%)
Cardiac disorders
Angina pectoris	1/1196 (0.1%)	1	0/224 (0%)	0
Cardiac disorder	1/1196 (0.1%)	1	0/224 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	1/1196 (0.1%)	1	0/224 (0%)	0
Nervous system disorders
Cerebrovascular accident	1/1196 (0.1%)	1	0/224 (0%)	0
Vascular disorders
Thrombophlebitis superficial	1/1196 (0.1%)	1	0/224 (0%)	0
Other (Not Including Serious) Adverse Events
	Oracea® as Monotherapy		Oracea® as add-on Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1196 (0%)		0/224 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.