Trial Outcomes & Findings for CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study (NCT NCT01493947)

Last Updated: 2015-10-28

Results Overview

Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

962 participants

Primary outcome timeframe

Baseline and Week 16

Results posted on

2015-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	Ivermectin Ivermectin applied once daily on the face during 16-week	Metronidazole 0.75% Cream Metronidazole 0.75% cream applied twice daily on the face during 16-week
Period A Efficacy and Safety Data STARTED	478	484
Period A Efficacy and Safety Data COMPLETED	446	456
Period A Efficacy and Safety Data NOT COMPLETED	32	28
Period B Extension Period STARTED	399	358
Period B Extension Period COMPLETED	366	326
Period B Extension Period NOT COMPLETED	33	32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ivermectin n=478 Participants Ivermectin: Ivermectin applied once daily on the face during 16-week plus 36-week extension period.	Metronidazole 0.75% Cream n=484 Participants Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.	Total n=962 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	394 Participants n=5 Participants	398 Participants n=7 Participants	792 Participants n=5 Participants
Age, Categorical >=65 years	84 Participants n=5 Participants	86 Participants n=7 Participants	170 Participants n=5 Participants
Sex: Female, Male Female	311 Participants n=5 Participants	316 Participants n=7 Participants	627 Participants n=5 Participants
Sex: Female, Male Male	167 Participants n=5 Participants	168 Participants n=7 Participants	335 Participants n=5 Participants
Region of Enrollment Czech Republic	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants
Region of Enrollment Russian Federation	39 participants n=5 Participants	35 participants n=7 Participants	74 participants n=5 Participants
Region of Enrollment Romania	57 participants n=5 Participants	52 participants n=7 Participants	109 participants n=5 Participants
Region of Enrollment Hungary	76 participants n=5 Participants	84 participants n=7 Participants	160 participants n=5 Participants
Region of Enrollment Ukraine	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
Region of Enrollment Poland	57 participants n=5 Participants	57 participants n=7 Participants	114 participants n=5 Participants
Region of Enrollment United Kingdom	16 participants n=5 Participants	19 participants n=7 Participants	35 participants n=5 Participants
Region of Enrollment Bulgaria	20 participants n=5 Participants	17 participants n=7 Participants	37 participants n=5 Participants
Region of Enrollment France	31 participants n=5 Participants	36 participants n=7 Participants	67 participants n=5 Participants
Region of Enrollment Germany	112 participants n=5 Participants	114 participants n=7 Participants	226 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 16

Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period

Outcome measures

Outcome measures
Measure	Ivermectin n=478 Participants Ivermectin: Ivermectin applied once daily on the face during 16-week plus 36-week extension period.	Metronidazole 0.75% Cream n=484 Participants Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
Percent Change in Inflammatory Lesions From Baseline to Week 16	-83 percentage of change Standard Deviation 26	-73.7 percentage of change Standard Deviation 39.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 16 up to Week 52

Relapse define as time elapsed between Week 16 and first reoccurrence of Investigator Global assessement (IGA) at '2 (mild)' , '3 (moderate)' or '4 (severe)'.

Outcome measures

Outcome measures
Measure	Ivermectin n=399 Participants Ivermectin: Ivermectin applied once daily on the face during 16-week plus 36-week extension period.	Metronidazole 0.75% Cream n=358 Participants Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
Time to Relapse	115 Median days to relapse Interval 113.0 to 165.0	85 Median days to relapse Interval 85.0 to 113.0

Adverse Events

Ivermectin 1% Cream Period A

Serious events: 8 serious events

Other events: 101 other events

Deaths: 0 deaths

Metronidazole 0.75% Cream Period A

Serious events: 5 serious events

Other events: 100 other events

Deaths: 0 deaths

Ivermectin 1% Cream Period B

Serious events: 10 serious events

Other events: 110 other events

Deaths: 0 deaths

Metronidazole 0.75% Cream Period B

Serious events: 11 serious events

Other events: 91 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Galderma CPM

Galderma R&D

Phone: 00 33 4 93 95 70 70

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Ivermectin 1% Cream Period A n=478 participants at risk Ivermectin applied once daily on the face during 16-week	Metronidazole 0.75% Cream Period A n=484 participants at risk Metronidazole 0.75% cream applied twice daily on the face during 16-week	Ivermectin 1% Cream Period B n=399 participants at risk 36-week extension period :only subjects with an IGA of 0 or 1 at Week 16 (i.e., at the last visit of Period A) were eligible	Metronidazole 0.75% Cream Period B n=359 participants at risk 36-week extension period : only subjects with an IGA of 0 or 1 at Week 16 (i.e., at the last visit of Period A) were eligible.
Infections and infestations Nasopharingitis	6.7% 32/478 • Number of events 32 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	6.0% 29/484 • Number of events 29 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	9.3% 37/399 • Number of events 37 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	10.9% 39/359 • Number of events 39 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.
Infections and infestations Influenza	1.9% 9/478 • Number of events 9 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	2.1% 10/484 • Number of events 10 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	3.0% 12/399 • Number of events 12 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.7% 6/359 • Number of events 6 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.
Nervous system disorders Headache	3.1% 15/478 • Number of events 15 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	2.3% 11/484 • Number of events 11 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.3% 5/399 • Number of events 5 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.1% 4/359 • Number of events 4 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.
Musculoskeletal and connective tissue disorders Back Pain	1.5% 7/478 • Number of events 7 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.83% 4/484 • Number of events 4 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.5% 6/399 • Number of events 6 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.4% 5/359 • Number of events 5 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.
Infections and infestations Bronchitis	1.3% 6/478 • Number of events 6 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.83% 4/484 • Number of events 4 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.0% 4/399 • Number of events 4 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.84% 3/359 • Number of events 3 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.
Vascular disorders Hypertension	1.3% 6/478 • Number of events 6 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.83% 4/484 • Number of events 4 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.0% 4/399 • Number of events 4 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.9% 7/359 • Number of events 7 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.
Infections and infestations Upper Respiratory Tract Infection	1.3% 6/478 • Number of events 6 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.83% 4/484 • Number of events 4 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.25% 1/399 • Number of events 1 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.00% 0/359 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	1.0% 5/478 • Number of events 5 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.21% 1/484 • Number of events 1 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.00% 0/399 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.28% 1/359 • Number of events 1 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.
Infections and infestations Oral Herpes	0.63% 3/478 • Number of events 3 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.0% 5/484 • Number of events 5 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.8% 7/399 • Number of events 7 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.84% 3/359 • Number of events 3 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.
Musculoskeletal and connective tissue disorders Arthralgia	0.21% 1/478 • Number of events 1 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.2% 6/484 • Number of events 6 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.0% 4/399 • Number of events 4 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.56% 2/359 • Number of events 2 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.
Eye disorders Conjunctivitis	0.21% 1/478 • Number of events 1 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.0% 5/484 • Number of events 5 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.0% 4/399 • Number of events 4 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.28% 1/359 • Number of events 1 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.
Skin and subcutaneous tissue disorders Pruritus	0.21% 1/478 • Number of events 1 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.0% 5/484 • Number of events 5 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.75% 3/399 • Number of events 3 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.00% 0/359 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.
Infections and infestations Pharyngitis	0.63% 3/478 • Number of events 3 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.83% 4/484 • Number of events 4 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.3% 5/399 • Number of events 5 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.7% 6/359 • Number of events 6 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.
Infections and infestations Viral Upper Respiratory Tract Infection	0.00% 0/478 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.21% 1/484 • Number of events 1 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.3% 5/399 • Number of events 5 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.56% 2/359 • Number of events 2 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.
Musculoskeletal and connective tissue disorders Arthritis	0.21% 1/478 • Number of events 1 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.21% 1/484 • Number of events 1 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.0% 4/399 • Number of events 4 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.28% 1/359 • Number of events 1 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.
Respiratory, thoracic and mediastinal disorders Rhinitis	0.42% 2/478 • Number of events 2 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.62% 3/484 • Number of events 3 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.0% 4/399 • Number of events 4 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.56% 2/359 • Number of events 2 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.
Respiratory, thoracic and mediastinal disorders Cough	0.63% 3/478 • Number of events 3 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.41% 2/484 • Number of events 2 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.75% 3/399 • Number of events 3 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.1% 4/359 • Number of events 4 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.
Infections and infestations Urinary Tract Infection	0.00% 0/478 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.21% 1/484 • Number of events 1 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	0.50% 2/399 • Number of events 2 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.	1.4% 5/359 • Number of events 5 One subject received Ivermectin in Period A,but after relapse received metronidazole in Period B. This subject was counted in each group, but the Adverse Events (AEs) are counted according to their onset date.