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Trial record 42 of 103 for:    IVERMECTIN

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

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ClinicalTrials.gov Identifier: NCT01493947
Recruitment Status : Completed
First Posted : December 16, 2011
Results First Posted : October 28, 2015
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Papulopustular Rosacea
Interventions Drug: Ivermectin 1% cream
Drug: Metronidazole 0.75% cream
Enrollment 962
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ivermectin Metronidazole 0.75% Cream
Hide Arm/Group Description Ivermectin applied once daily on the face during 16-week Metronidazole 0.75% cream applied twice daily on the face during 16-week
Period Title: Period A Efficacy and Safety Data
Started 478 484
Completed 446 456
Not Completed 32 28
Period Title: Period B Extension Period
Started 399 [1] 358 [2]
Completed 366 326
Not Completed 33 32
[1]
Only 399 /446 subjects were eligible to enter in Period B (i.e IGA=0 or1 at end of Period A).
[2]
358 / 456 subjects were eligible to enter in Period B (i.e IGA =0 or 1 at end of Period A).
Arm/Group Title Ivermectin Metronidazole 0.75% Cream Total
Hide Arm/Group Description Ivermectin: Ivermectin applied once daily on the face during 16-week plus 36-week extension period. Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period. Total of all reporting groups
Overall Number of Baseline Participants 478 484 962
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 478 participants 484 participants 962 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
394
  82.4%
398
  82.2%
792
  82.3%
>=65 years
84
  17.6%
86
  17.8%
170
  17.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 478 participants 484 participants 962 participants
Female
311
  65.1%
316
  65.3%
627
  65.2%
Male
167
  34.9%
168
  34.7%
335
  34.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 478 participants 484 participants 962 participants
Czech Republic 40 40 80
Russian Federation 39 35 74
Romania 57 52 109
Hungary 76 84 160
Ukraine 30 30 60
Poland 57 57 114
United Kingdom 16 19 35
Bulgaria 20 17 37
France 31 36 67
Germany 112 114 226
1.Primary Outcome
Title Percent Change in Inflammatory Lesions From Baseline to Week 16
Hide Description Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period
Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ivermectin Metronidazole 0.75% Cream
Hide Arm/Group Description:
Ivermectin: Ivermectin applied once daily on the face during 16-week plus 36-week extension period.
Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
Overall Number of Participants Analyzed 478 484
Mean (Standard Deviation)
Unit of Measure: percentage of change
-83  (26) -73.7  (39.7)
2.Other Pre-specified Outcome
Title Time to Relapse
Hide Description Relapse define as time elapsed between Week 16 and first reoccurrence of Investigator Global assessement (IGA) at '2 (mild)' , '3 (moderate)' or '4 (severe)'.
Time Frame Week 16 up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CD5024 Metronidazole 0.75% Cream
Hide Arm/Group Description:
CD5024: CD5024 applied once daily on the face during 16-week plus 36-week extension period.
Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
Overall Number of Participants Analyzed 399 358
Median (95% Confidence Interval)
Unit of Measure: Median days to relapse
115
(113 to 165)
85
(85 to 113)
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title Ivermectin 1% Cream Period A Metronidazole 0.75% Cream Period A Ivermectin 1% Cream Period B Metronidazole 0.75% Cream Period B
Hide Arm/Group Description Ivermectin applied once daily on the face during 16-week Metronidazole 0.75% cream applied twice daily on the face during 16-week 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 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.
All-Cause Mortality
Ivermectin 1% Cream Period A Metronidazole 0.75% Cream Period A Ivermectin 1% Cream Period B Metronidazole 0.75% Cream Period B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ivermectin 1% Cream Period A Metronidazole 0.75% Cream Period A Ivermectin 1% Cream Period B Metronidazole 0.75% Cream Period B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/478 (1.67%)      5/484 (1.03%)      10/399 (2.51%)      11/359 (3.06%)    
Cardiac disorders         
Atrial Fibrillation  1  0/478 (0.00%)  0 0/484 (0.00%)  0 1/399 (0.25%)  1 0/359 (0.00%)  0
Coronary Artery Disease  1  0/478 (0.00%)  0 1/484 (0.21%)  1 0/399 (0.00%)  0 1/359 (0.28%)  1
Congenital, familial and genetic disorders         
Vitello-Intestinal Duct Remnant  1  0/478 (0.00%)  0 0/484 (0.00%)  0 1/399 (0.25%)  1 0/359 (0.00%)  0
Eye disorders         
Macular Degeneration  1  0/478 (0.00%)  0 0/484 (0.00%)  0 1/399 (0.25%)  1 0/359 (0.00%)  0
Cataract  1  0/478 (0.00%)  0 1/484 (0.21%)  1 0/399 (0.00%)  0 0/359 (0.00%)  0
Gastrointestinal disorders         
Ileus  1  0/478 (0.00%)  0 0/484 (0.00%)  0 1/399 (0.25%)  1 0/359 (0.00%)  0
Anal Fistula  1  0/478 (0.00%)  0 0/484 (0.00%)  0 0/399 (0.00%)  0 1/359 (0.28%)  1
Abdominal Pain  1  1/478 (0.21%)  1 0/484 (0.00%)  0 0/399 (0.00%)  0 0/359 (0.00%)  0
Inguinal Hernia  1  1/478 (0.21%)  1 1/484 (0.21%)  1 0/399 (0.00%)  0 0/359 (0.00%)  0
Infections and infestations         
Eczema Infected  1  0/478 (0.00%)  0 0/484 (0.00%)  0 1/399 (0.25%)  1 0/359 (0.00%)  0
Erysipelas  1  0/478 (0.00%)  0 0/484 (0.00%)  0 0/399 (0.00%)  0 1/359 (0.28%)  1
Paronychia  1  0/478 (0.00%)  0 0/484 (0.00%)  0 0/399 (0.00%)  0 1/359 (0.28%)  1
Respiratory Tract Infection Bacterial  1  0/478 (0.00%)  0 0/484 (0.00%)  0 0/399 (0.00%)  0 1/359 (0.28%)  1
Chronic Sinusitis  1  1/478 (0.21%)  1 0/484 (0.00%)  0 0/399 (0.00%)  0 0/359 (0.00%)  0
Pneumonia  1  1/478 (0.21%)  1 0/484 (0.00%)  0 0/399 (0.00%)  0 0/359 (0.00%)  0
Injury, poisoning and procedural complications         
Brain Herniation  1  0/478 (0.00%)  0 0/484 (0.00%)  0 1/399 (0.25%)  1 0/359 (0.00%)  0
Upper Limb Fracture  1  0/478 (0.00%)  0 0/484 (0.00%)  0 1/399 (0.25%)  1 0/359 (0.00%)  0
Whiplash Injury  1  1/478 (0.21%)  1 0/484 (0.00%)  0 0/399 (0.00%)  0 0/359 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Osteoathritis  1  0/478 (0.00%)  0 0/484 (0.00%)  0 1/399 (0.25%)  1 1/359 (0.28%)  1
Psoriatic Arthropathy  1  1/478 (0.21%)  1 0/484 (0.00%)  0 0/399 (0.00%)  0 0/359 (0.00%)  0
Spinal Column Stenosis  1  1/478 (0.21%)  1 0/484 (0.00%)  0 0/399 (0.00%)  0 0/359 (0.00%)  0
Musculoskeletal Chest Pain  1  0/478 (0.00%)  0 1/484 (0.21%)  1 0/399 (0.00%)  0 0/359 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Colon Cancer  1  0/478 (0.00%)  0 0/484 (0.00%)  0 0/399 (0.00%)  0 1/359 (0.28%)  1
Breast Cancer  1  0/478 (0.00%)  0 1/484 (0.21%)  1 0/399 (0.00%)  0 0/359 (0.00%)  0
Nervous system disorders         
Cerebrovascular Accident  1  0/478 (0.00%)  0 0/484 (0.00%)  0 1/399 (0.25%)  1 0/359 (0.00%)  0
Ischaemic Stroke  1  0/478 (0.00%)  0 0/484 (0.00%)  0 1/399 (0.25%)  1 1/359 (0.28%)  1
Partial Seizures  1  0/478 (0.00%)  0 0/484 (0.00%)  0 1/399 (0.25%)  1 0/359 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Abortion Spontaneous  1  0/478 (0.00%)  0 0/484 (0.00%)  0 1/399 (0.25%)  1 0/359 (0.00%)  0
Ectopic Pregnancy  1  0/478 (0.00%)  0 0/484 (0.00%)  0 0/399 (0.00%)  0 1/359 (0.28%)  1
Psychiatric disorders         
Panic Attack  1  0/478 (0.00%)  0 0/484 (0.00%)  0 0/399 (0.00%)  0 1/359 (0.28%)  1
Renal and urinary disorders         
Nephrolitiasis  1  0/478 (0.00%)  0 0/484 (0.00%)  0 1/399 (0.25%)  1 0/359 (0.00%)  0
Vascular disorders         
Hypertensive Crisis  1  1/478 (0.21%)  1 0/484 (0.00%)  0 0/399 (0.00%)  0 2/359 (0.56%)  2
Femoral Artery Occlusion  1  0/478 (0.00%)  0 0/484 (0.00%)  0 0/399 (0.00%)  0 1/359 (0.28%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Ivermectin 1% Cream Period A Metronidazole 0.75% Cream Period A Ivermectin 1% Cream Period B Metronidazole 0.75% Cream Period B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   101/478 (21.13%)      100/484 (20.66%)      110/399 (27.57%)      91/359 (25.35%)    
Eye disorders         
Conjunctivitis  1  1/478 (0.21%)  1 5/484 (1.03%)  5 4/399 (1.00%)  4 1/359 (0.28%)  1
Infections and infestations         
Nasopharingitis  1  32/478 (6.69%)  32 29/484 (5.99%)  29 37/399 (9.27%)  37 39/359 (10.86%)  39
Influenza  1  9/478 (1.88%)  9 10/484 (2.07%)  10 12/399 (3.01%)  12 6/359 (1.67%)  6
Bronchitis  1  6/478 (1.26%)  6 4/484 (0.83%)  4 4/399 (1.00%)  4 3/359 (0.84%)  3
Upper Respiratory Tract Infection  1  6/478 (1.26%)  6 4/484 (0.83%)  4 1/399 (0.25%)  1 0/359 (0.00%)  0
Oral Herpes  1  3/478 (0.63%)  3 5/484 (1.03%)  5 7/399 (1.75%)  7 3/359 (0.84%)  3
Pharyngitis  1  3/478 (0.63%)  3 4/484 (0.83%)  4 5/399 (1.25%)  5 6/359 (1.67%)  6
Viral Upper Respiratory Tract Infection  1  0/478 (0.00%)  0 1/484 (0.21%)  1 5/399 (1.25%)  5 2/359 (0.56%)  2
Urinary Tract Infection  1  0/478 (0.00%)  0 1/484 (0.21%)  1 2/399 (0.50%)  2 5/359 (1.39%)  5
Musculoskeletal and connective tissue disorders         
Back Pain  1  7/478 (1.46%)  7 4/484 (0.83%)  4 6/399 (1.50%)  6 5/359 (1.39%)  5
Arthralgia  1  1/478 (0.21%)  1 6/484 (1.24%)  6 4/399 (1.00%)  4 2/359 (0.56%)  2
Arthritis  1  1/478 (0.21%)  1 1/484 (0.21%)  1 4/399 (1.00%)  4 1/359 (0.28%)  1
Nervous system disorders         
Headache  1  15/478 (3.14%)  15 11/484 (2.27%)  11 5/399 (1.25%)  5 4/359 (1.11%)  4
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal Pain  1  5/478 (1.05%)  5 1/484 (0.21%)  1 0/399 (0.00%)  0 1/359 (0.28%)  1
Rhinitis  1  2/478 (0.42%)  2 3/484 (0.62%)  3 4/399 (1.00%)  4 2/359 (0.56%)  2
Cough  1  3/478 (0.63%)  3 2/484 (0.41%)  2 3/399 (0.75%)  3 4/359 (1.11%)  4
Skin and subcutaneous tissue disorders         
Pruritus  1  1/478 (0.21%)  1 5/484 (1.03%)  5 3/399 (0.75%)  3 0/359 (0.00%)  0
Vascular disorders         
Hypertension  1  6/478 (1.26%)  6 4/484 (0.83%)  4 4/399 (1.00%)  4 7/359 (1.95%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Galderma CPM
Organization: Galderma R&D
Phone: 00 33 4 93 95 70 70
EMail: clinicaltrials@galderma.com
Layout table for additonal information
Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01493947     History of Changes
Other Study ID Numbers: RD.03.SPR.40173
First Submitted: December 15, 2011
First Posted: December 16, 2011
Results First Submitted: June 29, 2015
Results First Posted: October 28, 2015
Last Update Posted: October 28, 2015