Trial Outcomes & Findings for ORCA - Oracea® for Rosacea: A Community-based Assessment (NCT NCT00892281)

Last Updated: 2022-08-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1421 participants

Primary outcome timeframe

Baseline to Week 12

Results posted on

2022-08-25

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure	Oracea® as Monotherapy Oracea® 40 mg per day as monotherapy.	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.
Overall Study STARTED	1197	224
Overall Study COMPLETED	930	187
Overall Study NOT COMPLETED	267	37

Reasons for withdrawal

Reasons for withdrawal
Measure	Oracea® as Monotherapy Oracea® 40 mg per day as monotherapy.	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.
Overall Study Adverse Event	65	8
Overall Study Lost to Follow-up	81	8
Overall Study Pregnancy	1	0
Overall Study Protocol Violation	7	2
Overall Study Withdrawal by Subject	86	14
Overall Study Subject failed to return for final visit	2	0
Overall Study Subject unable to keep follow-up visits	1	0
Overall Study Final visit completed 4 weeks late	0	1
Overall Study Subject completed day after study closed	1	0
Overall Study Family emergency	1	0
Overall Study Last visit not done - death in family	1	0
Overall Study Did not meet incl/excl criteria	1	0
Overall Study Rosacea cleared; subject D/C'd self	1	0
Overall Study Unable to redeem the drug voucher	1	0
Overall Study Subject not good candidate for study	1	0
Overall Study Subject did not return for any visits	1	0
Overall Study Subject missed several visits/lost meds	1	0
Overall Study Missed Visit 4 and off meds for 65 days	1	1
Overall Study Scheduled for knee replacement	0	1
Overall Study PI complained of inadequate compensation	3	0
Overall Study Subject lost interest in program	0	1
Overall Study Bad taste in mouth after taking Oracea®	0	1
Overall Study Death in family	1	0
Overall Study Lack of efficacy of study product	2	0
Overall Study Subject not seen by PI at final visit	1	0
Overall Study No show Visit 2; prescription not filled	1	0
Overall Study Missed multiple visits	1	0
Overall Study Missed visits rescheduled out of window	1	0
Overall Study Non-compliant with visits as scheduled	1	0
Overall Study Subject had history of drug abuse	1	0
Overall Study Rash on hand	1	0
Overall Study Visit 4 date out of window	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oracea® as Monotherapy n=1197 Participants Oracea® 40 mg per day as monotherapy.	Oracea® as add-on Therapy n=224 Participants 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 n=1421 Participants Total of all reporting groups
Age, Continuous >=18 years	50.2 years STANDARD_DEVIATION 13.9 • n=5 Participants	53.4 years STANDARD_DEVIATION 12.9 • n=7 Participants	50.7 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	853 Participants n=5 Participants	154 Participants n=7 Participants	1007 Participants n=5 Participants
Sex: Female, Male Male	344 Participants n=5 Participants	70 Participants n=7 Participants	414 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: Per protocol

Outcome measures

Outcome measures
Measure	Oracea® as Monotherapy n=1197 Participants Oracea® 40 mg per day as monotherapy.	Oracea® as add-on Therapy n=224 Participants 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.
Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint +4 (worsening of rosacea by 4 IGA scale levels	0 participants	0 participants
Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint +3 (worsening of rosacea by 3 IGA scale levels)	0 participants	0 participants
Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint +2 (worsening of rosacea by 2 IGA scale levels)	0 participants	0 participants
Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint +1 (worsening of rosacea by 1 IGA scale level)	4 participants	4 participants
Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint 0 (no change in IGA scale level)	70 participants	11 participants
Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint -1 (improvement of rosacea by 1 IGA scale level	254 participants	42 participants
Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint -2 (improvement of rosacea by 2 IGA scale levels)	365 participants	65 participants
Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint -3 (improvement of rosacea by 3 IGA scale levels)	123 participants	14 participants
Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint -4 (improvement of rosacea by 4 IGA scale levels)	10 participants	4 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Oracea® as Monotherapy n=1197 Participants Oracea® 40 mg per day as monotherapy.	Oracea® as add-on Therapy n=224 Participants 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.
Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint +4 (worsening of erythema by 4 CEA scale levels)	0 participants	0 participants
Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint +3 (worsening of erythema by 3 CEA scale levels)	0 participants	0 participants
Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint +2 (worsening of erythema by 2 CEA scale levels)	0 participants	0 participants
Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint +1 (worsening of erythema by 1 CEA scale level)	6 participants	2 participants
Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint 0 (no change in CEA scale level)	97 participants	18 participants
Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint -1 (improvement in erythema by 1 CEA scale level)	415 participants	76 participants
Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint -2 (improvement in erythema by 2 CEA scale levels)	261 participants	38 participants
Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint -3 (improvement in erythema by 3 CEA scale levels)	45 participants	6 participants
Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint -4 (improvement of erythema by 4 CEA scale levels)	2 participants	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Oracea® as Monotherapy n=1197 Participants Oracea® 40 mg per day as monotherapy.	Oracea® as add-on Therapy n=224 Participants 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.
Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear)	616 participants	106 participants

Adverse Events

Oracea® as Monotherapy

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Oracea® as add-on Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oracea® as Monotherapy n=1196 participants at risk Oracea® 40 mg per day as monotherapy.	Oracea® as add-on Therapy n=224 participants at risk 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.
Cardiac disorders Angina pectoris	0.08% 1/1196 • Number of events 1 • 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.	0.00% 0/224 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.08% 1/1196 • Number of events 1 • 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.	0.00% 0/224 • 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.
Cardiac disorders Cardiac disorder	0.08% 1/1196 • Number of events 1 • 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.	0.00% 0/224 • 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.
Nervous system disorders Cerebrovascular accident	0.08% 1/1196 • Number of events 1 • 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.	0.00% 0/224 • 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.
Vascular disorders Thrombophlebitis superficial	0.08% 1/1196 • Number of events 1 • 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.	0.00% 0/224 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Ronald W. Gottschalk, MD / Medical Director

Galderma Laboratories, L.P.

Phone: 817-961-5358

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER