Phase 3 Papulopustular Rosacea Study
Sponsor
Galderma R&D (Industry)
Overall Status
Completed
CT.gov ID
NCT01493687
Collaborator
(none)
683
50
2
20
13.7
0.7
Study Details
Study Description
Brief Summary
The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
683 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Randomized, Double Blind, 12 Week Vehicle Controlled, Parallel Group Study Assessing the Efficacy and Safety of CD5024 1 % Cream Versus Vehicle Cream in Subjects With Papulopustular Rosacea, Followed by a 40 Week Investigator Blinded Extension Comparing the Long Term Safety of CD5024 1% Cream Versus Azelaic Acid 15 % Gel.
Study Start Date
:
Dec 1, 2011
Actual Primary Completion Date
:
Jul 1, 2013
Actual Study Completion Date
:
Aug 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CD5024 CD5024 1% Cream |
Drug: CD5024
CD5024 1% Cream, once daily
|
| Placebo Comparator: CD5024 Vehicle CD5024 Vehicle Cream |
Drug: Azelaic acid 15% Gel
Topical Gel applied twice daily
|
Outcome Measures
Primary Outcome Measures
- Success Rate [Week 12]
Percentage of subjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score. Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale: Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)
- Absolute Change in Inflammatory Lesion Count [Baseline to Week 12]
Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
Secondary Outcome Measures
- Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF) [Baseline to Week 12]
Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
The subject has papulopustular rosacea with an Investigator Global Assessment (IGA) score rated 3 (moderate) or 4 (severe),
-
The subject has at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.
Exclusion Criteria:
-
The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilaris, seborrheic dermatitis, and acne,
-
The subject has rosacea with more than two nodules on the face.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UAB Dermatology Clinical Research | Birmingham | Alabama | United States | 35233 |
| 2 | Northwest AR Clinical Trials Center | Rogers | Arkansas | United States | 72758 |
| 3 | Dermatology Research Associates | Los Angeles | California | United States | 30127 |
| 4 | University Clinical Trials | San Diego | California | United States | 92123 |
| 5 | Research Across America | Santa Ana | California | United States | 92705 |
| 6 | Cherry Creek Research, Inc. | Denver | Colorado | United States | 80209 |
| 7 | The Center for Clinical & Cosmetic Research | Aventura | Florida | United States | 33180 |
| 8 | The Dermatology and Aesthetic Center | Boca Raton | Florida | United States | 33486 |
| 9 | North Florida Dermatology Associates | Jacksonville | Florida | United States | 32204 |
| 10 | FXM Research Miramar | Miramar | Florida | United States | 33027 |
| 11 | MedaPhase, Inc. | Newnan | Georgia | United States | 30263 |
| 12 | Laser & Skin Surgery Center of Indiana | Carmel | Indiana | United States | 46032 |
| 13 | The Indiana Clinical Trials Center | Plainfield | Indiana | United States | 46168 |
| 14 | The South Bend Clinic, LLP | South Bend | Indiana | United States | 46617 |
| 15 | Derm Research, PLLC | Louisville | Kentucky | United States | 40217 |
| 16 | Lawrence Green, MD, LLC | Rockville | Maryland | United States | 20850 |
| 17 | Henry Ford Health Systems Department of Dermatology | Detroit | Michigan | United States | 48202 |
| 18 | Grekin Skin Institute | Warren | Michigan | United States | 48088 |
| 19 | Central Dermatology PC | Saint Louis | Missouri | United States | 63117 |
| 20 | Skin Specialists, PC | Omaha | Nebraska | United States | 68144 |
| 21 | Anderson & Collins Clinical Research, | Edison | New Jersey | United States | 08817 |
| 22 | PMG Research of Charlotte | Charlotte | North Carolina | United States | 28277 |
| 23 | Wake Research Associates | Raleigh | North Carolina | United States | 27612 |
| 24 | Department of Dermatology - Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
| 25 | Dermatology Research Center of Cincinnati | Cincinnati | Ohio | United States | 45220 |
| 26 | Haber Dermatology Clinical Research Center | South Euclid | Ohio | United States | 44118 |
| 27 | Central Sooner Research | Norman | Oklahoma | United States | 73071 |
| 28 | Baker Allergy, Asthma and Dermatology Research Center | Lake Oswego | Oregon | United States | 97035 |
| 29 | PMG Research of Charleston | Mount Pleasant | South Carolina | United States | 29464 |
| 30 | Palmetto Clinical Trial Services, LLC | Simpsonville | South Carolina | United States | 29681 |
| 31 | TriCities Skin and Cancer | Johnson City | Tennessee | United States | 37604 |
| 32 | Dermatology Associates of Kingsport, PC | Kingsport | Tennessee | United States | 37660 |
| 33 | DermResearch, Inc. | Austin | Texas | United States | 78759 |
| 34 | Modern Research Associates | Dallas | Texas | United States | 75231 |
| 35 | Center for Clinical Studies | Houston | Texas | United States | 77030 |
| 36 | Progressive Clinical Research | San Antonio | Texas | United States | 78229 |
| 37 | Dermatology Research Center, Inc. | Salt Lake City | Utah | United States | 84117 |
| 38 | The Education & Research Foundation, Inc. | Lynchburg | Virginia | United States | 24501 |
| 39 | PLLC dba Dermatology Associates | Seattle | Washington | United States | 98101 |
| 40 | The Polyclinic | Seattle | Washington | United States | 98122 |
| 41 | Stratica Medical Inc | Edmonton | Alberta | Canada | T5K 1X3 |
| 42 | Derm Research@888 Inc. | Vancouver | British Columbia | Canada | V5Z 3Y1 |
| 43 | Dermadvances Research | Winnepeg | Manitoba | Canada | R3C 1R4 |
| 44 | Nexus Clinical Research | St John's | Newfoundland and Labrador | Canada | A1A 5E8 |
| 45 | Eastern Canada Cutaneous Research Associates | Halifax | Nova Scotia | Canada | B3H 1Z4 |
| 46 | Skin Centre for Dermatology | Peterborough | Ontario | Canada | K9J 1Z2 |
| 47 | Toronto Research Centre, Inc. | Toronto | Ontario | Canada | M3H 5Y8 |
| 48 | Windsor Clinical Research, Inc. | Windsor | Ontario | Canada | N8W 5L7 |
| 49 | Innovaderm Research. Inc | Montreal | Quebec | Canada | H2K 4L5 |
| 50 | Siena Medical | Montreal | Quebec | Canada | H3Z 2S6 |
Sponsors and Collaborators
- Galderma R&D
Investigators
- Study Director: Michael Graeber, M.D., Galderma R&D, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Galderma R&D
ClinicalTrials.gov Identifier:
NCT01493687
Other Study ID Numbers:
- RD.06.SPR.18170
First Posted:
Dec 16, 2011
Last Update Posted:
Feb 18, 2021
Last Verified:
Jan 1, 2015
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | CD5024 1% Cream | CD5024 Vehicle Cream/Azelaic Acid 15% Gel |
|---|---|---|
| Arm/Group Description | Part A & B: CD5024 1% Cream, once daily application | Part A: CD5024 Vehicle Cream, once daily application Part B: Azelaic acid 15% Gel, twice daily application |
| Period Title: Part A Vehicle Control (12 Weeks) | ||
| STARTED | 451 | 232 |
| COMPLETED | 414 | 210 |
| NOT COMPLETED | 37 | 22 |
| Period Title: Part A Vehicle Control (12 Weeks) | ||
| STARTED | 412 | 210 |
| COMPLETED | 351 | 175 |
| NOT COMPLETED | 61 | 35 |
| Period Title: Part A Vehicle Control (12 Weeks) | ||
| STARTED | 350 | 175 |
| COMPLETED | 350 | 174 |
| NOT COMPLETED | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | CD5024 1% Cream | CD5024 Vehicle Cream/Azelaic Acid 15% Gel | Total |
|---|---|---|---|
| Arm/Group Description | Part A: CD5024 1% Cream, once daily application for 12 weeks Part B: CD5024 1% Cream, once daily application for 40 weeks | Part A: CD5024 Vehicle Cream, once daily application for 12 weeks Part B: Azelaic acid 15% Gel, twice daily application for 40 weeks | Total of all reporting groups |
| Overall Participants | 451 | 232 | 683 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
49.9
(12.15)
|
51.6
(11.92)
|
50.4
(12.09)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
314
69.6%
|
152
65.5%
|
466
68.2%
|
| Male |
137
30.4%
|
80
34.5%
|
217
31.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
55
12.2%
|
23
9.9%
|
78
11.4%
|
| Not Hispanic or Latino |
396
87.8%
|
209
90.1%
|
605
88.6%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
3
0.7%
|
3
1.3%
|
6
0.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
6
1.3%
|
3
1.3%
|
9
1.3%
|
| White |
437
96.9%
|
220
94.8%
|
657
96.2%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
5
1.1%
|
6
2.6%
|
11
1.6%
|
| Skin Photo Type (Number) [Number] | |||
| I |
39
8.6%
|
16
6.9%
|
55
8.1%
|
| II |
185
41%
|
90
38.8%
|
275
40.3%
|
| III |
167
37%
|
86
37.1%
|
253
37%
|
| IV |
51
11.3%
|
26
11.2%
|
77
11.3%
|
| V |
8
1.8%
|
11
4.7%
|
19
2.8%
|
| VI |
1
0.2%
|
3
1.3%
|
4
0.6%
|
Outcome Measures
| Title | Success Rate |
|---|---|
| Description | Percentage of subjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score. Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale: Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema) |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| LOCF, ITT |
| Arm/Group Title | CD5024 1% Cream | CD5024 Vehicle Cream |
|---|---|---|
| Arm/Group Description | CD5024: CD5024 1% Cream, once daily application for 12 weeks | CD5024 Vehicle Cream, once daily application for 12 weeks |
| Measure Participants | 451 | 232 |
| Number [Percentage of participants] |
38.4
8.5%
|
11.6
5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CD5024 1% Cream, CD5024 Vehicle Cream |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Absolute Change in Inflammatory Lesion Count |
|---|---|
| Description | Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek). |
| Time Frame | Baseline to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| LOCF, ITT |
| Arm/Group Title | CD5024 1% Cream | CD5024 Vehicle Cream |
|---|---|---|
| Arm/Group Description | CD5024: CD5024 1% Cream, once daily application for 12 weeks | CD5024 Vehicle Cream, once daily application for 12 weeks |
| Measure Participants | 451 | 232 |
| Mean (Standard Deviation) [Lesion count change] |
-20.5
(15.95)
|
-12.0
(13.55)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CD5024 1% Cream, CD5024 Vehicle Cream |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -8.13 | |
| Confidence Interval |
(2-Sided) 95% -10.12 to -6.13 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF) |
|---|---|
| Description | Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek). |
| Time Frame | Baseline to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| LOCF, ITT |
| Arm/Group Title | CD5024 1% Cream | CD5024 Vehicle Cream |
|---|---|---|
| Arm/Group Description | CD5024: CD5024 1% Cream, once daily application for 12 weeks | CD5024 Vehicle Cream, once daily application for 12 weeks |
| Measure Participants | 451 | 232 |
| Mean (Standard Deviation) [Percentage of change in lesion counts] |
-64.9
(39.91)
|
-41.6
(38.83)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CD5024 1% Cream, CD5024 Vehicle Cream |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Adverse Events
| Time Frame | Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose. | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||
| Arm/Group Title | CD5024 1% Cream - Part A | CD5024 Vehicle Cream - Part A | CD5024 1% Cream - Part B | Azelaic Acid 15% Gel - Part B | CD5024 1% Cream - Part C | CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C | CD5024 1% Cream - Overall | CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall | ||||||||
| Arm/Group Description | Part A: CD5024 1% Cream, once daily application for 12 weeks | Part A: CD5024 Vehicle Cream, once daily application for 12 weeks | Part B CD5024 1% Cream, once daily application for 40 weeks | Part B: Subjects in the CD5024 Vehicle Cream arm applied Azelaic Acid 15% Gel twice daily for 40 weeks | Part C: 4 week safety follow up. No drug applications | Part C: 4 week safety follow up. No drug applications | Overall number of subjects with adverse events for the entire duration of study | Overall number of subjects with adverse events for the entire duration of study | ||||||||
All Cause Mortality |
||||||||||||||||
| CD5024 1% Cream - Part A | CD5024 Vehicle Cream - Part A | CD5024 1% Cream - Part B | Azelaic Acid 15% Gel - Part B | CD5024 1% Cream - Part C | CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C | CD5024 1% Cream - Overall | CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||
Serious Adverse Events |
||||||||||||||||
| CD5024 1% Cream - Part A | CD5024 Vehicle Cream - Part A | CD5024 1% Cream - Part B | Azelaic Acid 15% Gel - Part B | CD5024 1% Cream - Part C | CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C | CD5024 1% Cream - Overall | CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/452 (0.7%) | 1/231 (0.4%) | 7/412 (1.7%) | 8/210 (3.8%) | 0/350 (0%) | 1/175 (0.6%) | 10/452 (2.2%) | 9/232 (3.9%) | ||||||||
| Cardiac disorders | ||||||||||||||||
| Coronary artery disease | 0/452 (0%) | 0/231 (0%) | 1/412 (0.2%) | 0/210 (0%) | 0/350 (0%) | 0/175 (0%) | 1/452 (0.2%) | 0/232 (0%) | ||||||||
| Acute myocardial infarction | 0/452 (0%) | 0/231 (0%) | 1/412 (0.2%) | 1/210 (0.5%) | 0/350 (0%) | 0/175 (0%) | 1/452 (0.2%) | 1/232 (0.4%) | ||||||||
| Atrioventricular block complete | 0/452 (0%) | 0/231 (0%) | 1/412 (0.2%) | 0/210 (0%) | 0/350 (0%) | 0/175 (0%) | 1/452 (0.2%) | 0/232 (0%) | ||||||||
| Atrial fibrillation | 0/452 (0%) | 0/231 (0%) | 0/412 (0%) | 2/210 (1%) | 0/350 (0%) | 0/175 (0%) | 0/452 (0%) | 2/232 (0.9%) | ||||||||
| Cardiogenic shock | 0/452 (0%) | 0/231 (0%) | 0/412 (0%) | 1/210 (0.5%) | 0/350 (0%) | 0/175 (0%) | 0/452 (0%) | 1/232 (0.4%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Oesophageal ulcer perforation | 0/452 (0%) | 0/231 (0%) | 1/412 (0.2%) | 0/210 (0%) | 0/350 (0%) | 0/175 (0%) | 1/452 (0.2%) | 0/232 (0%) | ||||||||
| Ascites | 0/452 (0%) | 0/231 (0%) | 0/412 (0%) | 0/210 (0%) | 0/350 (0%) | 1/175 (0.6%) | 0/452 (0%) | 1/232 (0.4%) | ||||||||
| Gastrointestinal haemorrhage | 0/452 (0%) | 0/231 (0%) | 0/412 (0%) | 1/210 (0.5%) | 0/350 (0%) | 0/175 (0%) | 0/452 (0%) | 1/232 (0.4%) | ||||||||
| Hepatobiliary disorders | ||||||||||||||||
| Cholelithiasis | 0/452 (0%) | 0/231 (0%) | 1/412 (0.2%) | 0/210 (0%) | 0/350 (0%) | 0/175 (0%) | 1/452 (0.2%) | 0/232 (0%) | ||||||||
| Cholecystitis | 1/452 (0.2%) | 0/231 (0%) | 0/412 (0%) | 0/210 (0%) | 0/350 (0%) | 0/175 (0%) | 1/452 (0.2%) | 0/232 (0%) | ||||||||
| Infections and infestations | ||||||||||||||||
| Gastroenteritis viral | 0/452 (0%) | 0/231 (0%) | 1/412 (0.2%) | 0/210 (0%) | 0/350 (0%) | 0/175 (0%) | 1/452 (0.2%) | 0/232 (0%) | ||||||||
| Lobar pneumonia | 0/452 (0%) | 0/231 (0%) | 0/412 (0%) | 1/210 (0.5%) | 0/350 (0%) | 0/175 (0%) | 0/452 (0%) | 1/232 (0.4%) | ||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||
| Femoral neck fracture | 0/452 (0%) | 0/231 (0%) | 0/412 (0%) | 1/210 (0.5%) | 0/350 (0%) | 0/175 (0%) | 0/452 (0%) | 1/232 (0.4%) | ||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||
| Transitional cell carcinoma | 0/452 (0%) | 0/231 (0%) | 1/412 (0.2%) | 0/210 (0%) | 0/350 (0%) | 0/175 (0%) | 1/452 (0.2%) | 0/232 (0%) | ||||||||
| Breast cancer | 0/452 (0%) | 0/231 (0%) | 1/412 (0.2%) | 0/210 (0%) | 0/350 (0%) | 0/175 (0%) | 1/452 (0.2%) | 0/232 (0%) | ||||||||
| Squamous cell carcinoma of skin | 0/452 (0%) | 0/231 (0%) | 1/412 (0.2%) | 0/210 (0%) | 0/350 (0%) | 0/175 (0%) | 1/452 (0.2%) | 0/232 (0%) | ||||||||
| Pancreatic carcinoma | 0/452 (0%) | 0/231 (0%) | 0/412 (0%) | 0/210 (0%) | 0/350 (0%) | 1/175 (0.6%) | 0/452 (0%) | 1/232 (0.4%) | ||||||||
| Uterine leiomyoma | 0/452 (0%) | 0/231 (0%) | 0/412 (0%) | 1/210 (0.5%) | 0/350 (0%) | 0/175 (0%) | 0/452 (0%) | 1/232 (0.4%) | ||||||||
| Colon cancer | 0/452 (0%) | 0/231 (0%) | 0/412 (0%) | 1/210 (0.5%) | 0/350 (0%) | 0/175 (0%) | 0/452 (0%) | 1/232 (0.4%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| Transient ischaemic attack | 0/452 (0%) | 0/231 (0%) | 1/412 (0.2%) | 2/210 (1%) | 0/350 (0%) | 0/175 (0%) | 1/452 (0.2%) | 2/232 (0.9%) | ||||||||
| Pregnancy, puerperium and perinatal conditions | ||||||||||||||||
| Intra-uterine death | 1/452 (0.2%) | 0/231 (0%) | 0/412 (0%) | 0/210 (0%) | 0/350 (0%) | 0/175 (0%) | 1/452 (0.2%) | 0/232 (0%) | ||||||||
| Renal and urinary disorders | ||||||||||||||||
| Nephrolithiasis | 0/452 (0%) | 0/231 (0%) | 1/412 (0.2%) | 0/210 (0%) | 0/350 (0%) | 0/175 (0%) | 1/452 (0.2%) | 0/232 (0%) | ||||||||
| Renal failure acute | 0/452 (0%) | 0/231 (0%) | 0/412 (0%) | 2/210 (1%) | 0/350 (0%) | 0/175 (0%) | 0/452 (0%) | 2/232 (0.9%) | ||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Chronic obstructive pulmonary disease | 1/452 (0.2%) | 0/231 (0%) | 0/412 (0%) | 0/210 (0%) | 0/350 (0%) | 0/175 (0%) | 1/452 (0.2%) | 0/232 (0%) | ||||||||
| Vascular disorders | ||||||||||||||||
| Femoral arterial stenosis | 0/452 (0%) | 0/231 (0%) | 1/412 (0.2%) | 0/210 (0%) | 0/350 (0%) | 0/175 (0%) | 1/452 (0.2%) | 0/232 (0%) | ||||||||
| Shock | 0/452 (0%) | 0/231 (0%) | 0/412 (0%) | 1/210 (0.5%) | 0/350 (0%) | 0/175 (0%) | 0/452 (0%) | 1/232 (0.4%) | ||||||||
| Hypotension | 0/452 (0%) | 1/231 (0.4%) | 0/412 (0%) | 0/210 (0%) | 0/350 (0%) | 0/175 (0%) | 0/452 (0%) | 1/232 (0.4%) | ||||||||
| Haemorrhagic anaemia | 0/452 (0%) | 1/231 (0.4%) | 0/412 (0%) | 0/210 (0%) | 0/350 (0%) | 0/175 (0%) | 0/452 (0%) | 1/232 (0.4%) | ||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| CD5024 1% Cream - Part A | CD5024 Vehicle Cream - Part A | CD5024 1% Cream - Part B | Azelaic Acid 15% Gel - Part B | CD5024 1% Cream - Part C | CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C | CD5024 1% Cream - Overall | CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 30/452 (6.6%) | 10/231 (4.3%) | 93/412 (22.6%) | 47/210 (22.4%) | 4/350 (1.1%) | 0/175 (0%) | 110/452 (24.3%) | 52/232 (22.4%) | ||||||||
| Infections and infestations | ||||||||||||||||
| Nasopharyngitis | 12/452 (2.7%) | 6/231 (2.6%) | 54/412 (13.1%) | 31/210 (14.8%) | 1/350 (0.3%) | 0/175 (0%) | 63/452 (13.9%) | 34/232 (14.7%) | ||||||||
| Upper respiratory tract infection | 6/452 (1.3%) | 2/231 (0.9%) | 31/412 (7.5%) | 14/210 (6.7%) | 2/350 (0.6%) | 0/175 (0%) | 37/452 (8.2%) | 16/232 (6.9%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| Headache | 13/452 (2.9%) | 4/231 (1.7%) | 17/412 (4.1%) | 8/210 (3.8%) | 1/350 (0.3%) | 0/175 (0%) | 26/452 (5.8%) | 10/232 (4.3%) | ||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
At least sixty (60) days prior to submission for publication, presentation or use, the Institution and the Investigator shall submit in writing to the Contract Research Organization and Sponsor for review and comment any proposed oral or written publication, which period may be extended for an additional thirty (30) days if requested in writing by Contract Research Organization and Sponsor.
Results Point of Contact
| Name/Title | Clinical Science Director |
|---|---|
| Organization | Galderma R&D, LLC |
| Phone | 609-409-7701 |
Responsible Party:
Galderma R&D
ClinicalTrials.gov Identifier:
NCT01493687
Other Study ID Numbers:
- RD.06.SPR.18170
First Posted:
Dec 16, 2011
Last Update Posted:
Feb 18, 2021
Last Verified:
Jan 1, 2015