Phase 3 Papulopustular Rosacea Study
Sponsor
Galderma R&D (Industry)
Overall Status
Completed
CT.gov ID
NCT01494467
Collaborator
(none)
688
50
2
20
13.8
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
:
688 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
:
Aug 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 | Total Skin and Beauty | Birmingham | Alabama | United States | 35205 |
| 2 | Coastal Clinical Research, Inc. | Mobile | Alabama | United States | 36608 |
| 3 | Burke Pharmaceutical Research | Hot Springs | Arkansas | United States | 71913 |
| 4 | Dermatology Specialists, Inc | Oceanside | California | United States | 92056 |
| 5 | Integrated Research Group, Inc | Riverside | California | United States | 92506 |
| 6 | Therapeutics Clinical Research | San Diego | California | United States | 92123 |
| 7 | University of California, San Francisco | San Francisco | California | United States | 94143 |
| 8 | ATS Clinical Research | Santa Monica | California | United States | 90404 |
| 9 | Redwood Dermatology Research | Santa Rosa | California | United States | 95403 |
| 10 | FXM Research Corp Miami | Miami | Florida | United States | 33175 |
| 11 | Leavitt Medical Associates of Florida dba Ameriderm Research | Ormond Beach | Florida | United States | |
| 12 | Atlanta Dermatology, Vein & Research Center, LLC | Alpharetta | Georgia | United States | 30022 |
| 13 | Emory University | Atlanta | Georgia | United States | 30322 |
| 14 | Altman Dermatology Associates | Arlington Heights | Illinois | United States | 60005 |
| 15 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 16 | Deaconess Clinic, Inc. | Evansville | Indiana | United States | 47713 |
| 17 | Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | United States | 46256 |
| 18 | Dermatology Specialists Research | Louisville | Kentucky | United States | 40202 |
| 19 | Northeast Dermatology Associates | Beverly | Massachusetts | United States | 01915 |
| 20 | David Fivenson, MD, PLC | Ann Arbor | Michigan | United States | 48103 |
| 21 | Hamzavi Dermatology | Fort Gratiot | Michigan | United States | 48059 |
| 22 | Somerset Skin Centre | Troy | Michigan | United States | 48084 |
| 23 | Dermatology Clinical Trials Unit | Saint Louis | Missouri | United States | 63141 |
| 24 | Psoriasis Treatment Center of NJ | West Windsor | New Jersey | United States | |
| 25 | Academic Dermatology Associates | Albuquerque | New Mexico | United States | 87106 |
| 26 | DermResearch Center of New York, Inc | Stony Brook | New York | United States | 11790 |
| 27 | High Point | North Carolina | United States | 27262 | |
| 28 | PMG Research of Raleigh, LLC | Raleigh | North Carolina | United States | 27609 |
| 29 | Oregon Dermatology and Research Center | Portland | Oregon | United States | 97210 |
| 30 | Dermatology and Skin Surgery Center | Exton | Pennsylvania | United States | 19341 |
| 31 | Philadelphia Institute of Dermatology | Fort Washington | Pennsylvania | United States | 19034 |
| 32 | Penn State Hershey Medical Center | Hershey | Pennsylvania | United States | 17033 |
| 33 | Paddington Research | Philadelphia | Pennsylvania | United States | 19103 |
| 34 | Yardley Dermatology Associates | Yardley | Pennsylvania | United States | 19067 |
| 35 | The Skin Wellness Center | Knoxville | Tennessee | United States | 37922 |
| 36 | Dermatology Reserach Associates | Nashville | Tennessee | United States | 17203 |
| 37 | Arlington Research Center, Inc | Arlington | Texas | United States | 76011 |
| 38 | Stephen Miller MD | San Antonio | Texas | United States | 78229 |
| 39 | San Antonio | Texas | United States | 78229 | |
| 40 | Center for Clinical Studies | Webster | Texas | United States | 77598 |
| 41 | Guildford Dermatology Specialists | Surrey | British Columbia | Canada | V3R 6A7 |
| 42 | Ultranova Skincare | Barrie | Ontario | Canada | L4M 6L2 |
| 43 | Dermatrials Research | Hamilton | Ontario | Canada | L8N 1V6 |
| 44 | The Guenther Dermatology Research Center | London | Ontario | Canada | N6A 3H7 |
| 45 | Lynderm Research Inc | Markham | Ontario | Canada | L3P 1A8 |
| 46 | North Bay Dermatology Centre, Inc | North Bay | Ontario | Canada | P1B 3Z7 |
| 47 | The Centre for Dermatology & Cosmetic Surgery | Richmond Hill | Ontario | Canada | L4B 1A5 |
| 48 | XLR8 Medical Research, Inc | Windsor | Ontario | Canada | N8W 1E6 |
| 49 | International Dermatology Research, Inc | Montreal | Quebec | Canada | H3H 1V4 |
| 50 | Centre de Recherche Dermatologique du Quebec Metropolitan | Quebec | Canada | G1V 4X7 |
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:
NCT01494467
Other Study ID Numbers:
- RD.06.SPR.18171
First Posted:
Dec 19, 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 | 459 | 229 |
| COMPLETED | 429 | 208 |
| NOT COMPLETED | 30 | 21 |
| Period Title: Part A Vehicle Control (12 Weeks) | ||
| STARTED | 428 | 208 |
| COMPLETED | 353 | 159 |
| NOT COMPLETED | 75 | 49 |
| Period Title: Part A Vehicle Control (12 Weeks) | ||
| STARTED | 353 | 159 |
| COMPLETED | 353 | 159 |
| NOT COMPLETED | 0 | 0 |
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 | 459 | 229 | 688 |
| Age (Year) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Year] |
50.5
(12.35)
|
49.5
(12.16)
|
50.2
(12.29)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
314
68.4%
|
145
63.3%
|
459
66.7%
|
| Male |
145
31.6%
|
84
36.7%
|
229
33.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
56
12.2%
|
31
13.5%
|
87
12.6%
|
| Not Hispanic or Latino |
403
87.8%
|
198
86.5%
|
601
87.4%
|
| 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 |
10
2.2%
|
5
2.2%
|
15
2.2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
6
1.3%
|
4
1.7%
|
10
1.5%
|
| White |
438
95.4%
|
218
95.2%
|
656
95.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
5
1.1%
|
2
0.9%
|
7
1%
|
| Skin Photo Type (Number) [Number] | |||
| I |
48
10.5%
|
22
9.6%
|
70
10.2%
|
| II |
211
46%
|
96
41.9%
|
307
44.6%
|
| III |
139
30.3%
|
71
31%
|
210
30.5%
|
| IV |
50
10.9%
|
31
13.5%
|
81
11.8%
|
| V |
11
2.4%
|
7
3.1%
|
18
2.6%
|
| VI |
0
0%
|
2
0.9%
|
2
0.3%
|
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 1% Cream, once daily application for 12 weeks | CD5024 Vehicle Cream, once daily application for 12 weeks |
| Measure Participants | 459 | 229 |
| Number [Percentage of participants] |
40.1
8.7%
|
18.8
8.2%
|
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 1% Cream, once daily application for 12 weeks | CD5024 Vehicle Cream, once daily application for 12 weeks |
| Measure Participants | 459 | 229 |
| Mean (Standard Deviation) [Lesion count change] |
-22.2
(14.87)
|
-13.4
(14.48)
|
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 | -8.22 | |
| Confidence Interval |
(2-Sided) 95% -10.18 to -6.25 |
|
| 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 |
|---|
| [Not Specified] |
| Arm/Group Title | CD5024 1% Cream | CD5024 Vehicle Cream |
|---|---|---|
| Arm/Group Description | CD5024 1% Cream, once daily application for 12 weeks | CD5024 Vehicle Cream, once daily application for 12 weeks |
| Measure Participants | 459 | 229 |
| Mean (Standard Deviation) [Percentage of change in lesion counts] |
-65.7
(33.18)
|
-43.4
(38.42)
|
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 | Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects). | |||||||||||||||
| 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 | 7/458 (1.5%) | 4/230 (1.7%) | 13/428 (3%) | 4/208 (1.9%) | 0/353 (0%) | 1/159 (0.6%) | 18/460 (3.9%) | 9/231 (3.9%) | ||||||||
| Cardiac disorders | ||||||||||||||||
| Atrial fibrillation | 1/458 (0.2%) | 0/230 (0%) | 1/428 (0.2%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 2/460 (0.4%) | 0/231 (0%) | ||||||||
| Angina pectoris | 0/458 (0%) | 0/230 (0%) | 1/428 (0.2%) | 1/208 (0.5%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 1/231 (0.4%) | ||||||||
| Myocardial ischaemia | 1/458 (0.2%) | 0/230 (0%) | 0/428 (0%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 0/231 (0%) | ||||||||
| Sick sinus syndrome | 0/458 (0%) | 0/230 (0%) | 1/428 (0.2%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 0/231 (0%) | ||||||||
| Cardiac failure | 0/458 (0%) | 0/230 (0%) | 1/428 (0.2%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 0/231 (0%) | ||||||||
| Aortic valve stenosis | 0/458 (0%) | 0/230 (0%) | 0/428 (0%) | 1/208 (0.5%) | 0/353 (0%) | 0/159 (0%) | 0/460 (0%) | 1/231 (0.4%) | ||||||||
| Ear and labyrinth disorders | ||||||||||||||||
| Vertigo | 1/458 (0.2%) | 0/230 (0%) | 0/428 (0%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 0/231 (0%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Colonic obstruction | 0/458 (0%) | 0/230 (0%) | 1/428 (0.2%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 0/231 (0%) | ||||||||
| General disorders | ||||||||||||||||
| Chest discomfort | 0/458 (0%) | 0/230 (0%) | 0/428 (0%) | 1/208 (0.5%) | 0/353 (0%) | 0/159 (0%) | 0/460 (0%) | 1/231 (0.4%) | ||||||||
| Hepatobiliary disorders | ||||||||||||||||
| Cholecystis chronic | 1/458 (0.2%) | 0/230 (0%) | 0/428 (0%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 0/231 (0%) | ||||||||
| Cholecystitis | 0/458 (0%) | 0/230 (0%) | 1/428 (0.2%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 0/231 (0%) | ||||||||
| Immune system disorders | ||||||||||||||||
| Anaphylactic reaction | 1/458 (0.2%) | 0/230 (0%) | 0/428 (0%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 0/231 (0%) | ||||||||
| Infections and infestations | ||||||||||||||||
| Pneumonia | 1/458 (0.2%) | 0/230 (0%) | 0/428 (0%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 0/231 (0%) | ||||||||
| Diverticulitis | 0/458 (0%) | 0/230 (0%) | 0/428 (0%) | 1/208 (0.5%) | 0/353 (0%) | 0/159 (0%) | 0/460 (0%) | 1/231 (0.4%) | ||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||
| Forearm fracture | 0/458 (0%) | 0/230 (0%) | 1/428 (0.2%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 0/231 (0%) | ||||||||
| Postoperative ileus | 0/458 (0%) | 1/230 (0.4%) | 0/428 (0%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 0/460 (0%) | 1/231 (0.4%) | ||||||||
| Incisional hernia | 0/458 (0%) | 0/230 (0%) | 0/428 (0%) | 1/208 (0.5%) | 0/353 (0%) | 0/159 (0%) | 0/460 (0%) | 1/231 (0.4%) | ||||||||
| Metabolism and nutrition disorders | ||||||||||||||||
| Dehydration | 0/458 (0%) | 0/230 (0%) | 1/428 (0.2%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 0/231 (0%) | ||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Osteoarthritis | 0/458 (0%) | 0/230 (0%) | 1/428 (0.2%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 0/231 (0%) | ||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||
| Breast cancer | 0/458 (0%) | 0/230 (0%) | 1/428 (0.2%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 0/231 (0%) | ||||||||
| Oesophageal adenocarcinoma | 0/458 (0%) | 0/230 (0%) | 1/428 (0.2%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 0/231 (0%) | ||||||||
| B-cell lymphoma | 1/458 (0.2%) | 0/230 (0%) | 0/428 (0%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 0/231 (0%) | ||||||||
| Prostate cancer | 0/458 (0%) | 1/230 (0.4%) | 0/428 (0%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 0/460 (0%) | 1/231 (0.4%) | ||||||||
| Colon adenoma | 0/458 (0%) | 1/230 (0.4%) | 0/428 (0%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 0/460 (0%) | 1/231 (0.4%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| Multiple sclerosis | 0/458 (0%) | 0/230 (0%) | 1/428 (0.2%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 0/231 (0%) | ||||||||
| Cerebrovascular accident | 0/458 (0%) | 0/230 (0%) | 1/428 (0.2%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 0/231 (0%) | ||||||||
| Headache | 0/458 (0%) | 0/230 (0%) | 0/428 (0%) | 1/208 (0.5%) | 0/353 (0%) | 0/159 (0%) | 0/460 (0%) | 1/231 (0.4%) | ||||||||
| Transient ischaemic attack | 0/458 (0%) | 0/230 (0%) | 0/428 (0%) | 1/208 (0.5%) | 0/353 (0%) | 0/159 (0%) | 0/460 (0%) | 1/231 (0.4%) | ||||||||
| Pregnancy, puerperium and perinatal conditions | ||||||||||||||||
| Abortion spontaneous | 0/458 (0%) | 0/230 (0%) | 1/428 (0.2%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 0/231 (0%) | ||||||||
| Psychiatric disorders | ||||||||||||||||
| Depression | 2/458 (0.4%) | 0/230 (0%) | 0/428 (0%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 2/460 (0.4%) | 0/231 (0%) | ||||||||
| Alcohol withdrawal syndrome | 0/458 (0%) | 0/230 (0%) | 1/428 (0.2%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 0/231 (0%) | ||||||||
| Major depression | 0/458 (0%) | 1/230 (0.4%) | 0/428 (0%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 0/460 (0%) | 1/231 (0.4%) | ||||||||
| Renal and urinary disorders | ||||||||||||||||
| Nephrolithiasis | 0/458 (0%) | 0/230 (0%) | 0/428 (0%) | 0/208 (0%) | 0/353 (0%) | 1/159 (0.6%) | 0/460 (0%) | 1/231 (0.4%) | ||||||||
| Reproductive system and breast disorders | ||||||||||||||||
| Dysfunctional uterine bleeding | 0/458 (0%) | 0/230 (0%) | 1/428 (0.2%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 1/460 (0.2%) | 0/231 (0%) | ||||||||
| Menorrhagia | 0/458 (0%) | 1/230 (0.4%) | 0/428 (0%) | 0/208 (0%) | 0/353 (0%) | 0/159 (0%) | 0/460 (0%) | 1/231 (0.4%) | ||||||||
| Vascular disorders | ||||||||||||||||
| Hypertension | 0/458 (0%) | 1/230 (0.4%) | 0/428 (0%) | 1/208 (0.5%) | 0/353 (0%) | 0/159 (0%) | 0/460 (0%) | 2/231 (0.9%) | ||||||||
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 | 33/458 (7.2%) | 26/230 (11.3%) | 102/428 (23.8%) | 47/208 (22.6%) | 4/353 (1.1%) | 3/159 (1.9%) | 125/460 (27.2%) | 64/231 (27.7%) | ||||||||
| Infections and infestations | ||||||||||||||||
| Nasopharyngitis | 10/458 (2.2%) | 6/230 (2.6%) | 43/428 (10%) | 18/208 (8.7%) | 1/353 (0.3%) | 1/159 (0.6%) | 52/460 (11.3%) | 23/231 (10%) | ||||||||
| Upper respiratory tract infection | 12/458 (2.6%) | 8/230 (3.5%) | 40/428 (9.3%) | 17/208 (8.2%) | 1/353 (0.3%) | 2/159 (1.3%) | 48/460 (10.4%) | 23/231 (10%) | ||||||||
| Sinusitis | 9/458 (2%) | 6/230 (2.6%) | 20/428 (4.7%) | 7/208 (3.4%) | 2/353 (0.6%) | 0/159 (0%) | 30/460 (6.5%) | 13/231 (5.6%) | ||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Skin irritation | 3/458 (0.7%) | 7/230 (3%) | 4/428 (0.9%) | 8/208 (3.8%) | 0/353 (0%) | 0/159 (0%) | 6/460 (1.3%) | 15/231 (6.5%) | ||||||||
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:
NCT01494467
Other Study ID Numbers:
- RD.06.SPR.18171
First Posted:
Dec 19, 2011
Last Update Posted:
Feb 18, 2021
Last Verified:
Jan 1, 2015