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This was a multi-center, randomized, double-blind, parallel group study. Efficacy Objectives: To evaluate the efficacy of CD2027 ointment 3 mcg/g applied twice daily over 4 weeks versus its vehicle in adult participants with at least moderate atopic dermatitis.
Safety objective: To evaluate safety of CD2027 ointment 3 mcg/g when applied twice daily over 4 weeks versus its vehicle on 5 percent (%) - 20% involved Body Surface Area (BSA) (excluding Head/Neck) in adult participants with at least moderate atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD2027 Ointment 3 mcg/g, twice daily | Experimental | Participants applied 3 mcg/g CD2027 Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions. |
|
| Vehicle Ointment, twice daily | Placebo Comparator | Participants applied Vehicle Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD2027 Ointment 3 mcg/g, twice daily | Drug | Topical Ointment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Severity Score (TSS) of Target Lesion at Baseline and Week 4 | TSS comprised of the sum of an assessment of erythema, excoriation, exudation, lichenification and pruritus, each on a scale of 0 to 3 to give a maximum score of 15; 0 (best) and 3 (worst) indicated total possible minimum score was 0 and total possible maximum score was 15. Lower score meant improvement in condition and higher score indicated worsening of condition. | Baseline, Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Severity Score (TSS) for Individual Signs at Week 4 | TSS comprised of the sum of an assessment of erythema, excoriation, exudation, lichenification and pruritus, each on a scale of 0 to 3 to give a maximum score of 15; 0 (best) and 3 (Worst) indicated total possible minimum score was 0 and total possible maximum score was 15. Data for individual signs is reported in this outcome measure. Lower score meant improvement in condition and higher score indicated severity (worsening of condition) for each individual sign. Erythema was evaluated on a four point scale of 0 to 3 where (0=none, 1=mild, 2=moderate, 3=severe). Excoriation evaluated on a four point scale of 0 to 3 where (0=none, 1=mild, 2=moderate, 3=severe). Exudation was evaluated on a four point scale of 0 to 3 where (0=none, 1=mild, 2=moderate, 3=severe). Lichenification was evaluated on a four point scale of 0 to 3 where (0=none, 1=mild, 2=moderate, 3=severe). Pruritus was evaluated on a four point scale of 0 to 3 where (0=none, 1=mild, 2=moderate, 3=severe). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Graeber, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States | ||
| Therapeutics Clinical Research, Inc. |
A total of 147 participants were screened, of which 102 participants were enrolled and randomized to receive study treatment and 45 participants were reported as screen failure.
Participants took part in the study at 14 investigative sites in the United States from 21 May 2009 to 01 October 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | CD2027 Ointment 3 mcg/g, Twice Daily | Participants applied 3 microgram per gram (mcg/g) CD2027 Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions. |
| FG001 | Vehicle Ointment, Twice Daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Vehicle Ointment, twice daily |
| Drug |
Topical Ointment |
|
| Baseline, Week 4 |
| Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Failure From Baseline of Greater Than 1 Points Over Week 4 | IGA was an assessment scale used to determine severity of Atopic Dermatitis (AD) and clinical response to treatment on a 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of "0" or "1" and a failure from baseline of greater than (>1) points over 4 weeks were reported. | Baseline, Week 1, Week 2, Week 3, Week 4 |
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 1, 2, 3, 4 | The EASI score quantifies the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no eruption) to 6 (>90%-100% eruption). The total score was the sum of the four body-region scores, maximum=72, minimum=0, Higher scores indicated greater disease severity. | Baseline, Week1, Week2, Week 3, Week 4 |
| San Diego |
| California |
| 92123 |
| United States |
| Colorado Medical Research Center, Inc. | Denver | Colorado | 80120 | United States |
| Longmont Medical Research Network | Longmont | Colorado | 80501 | United States |
| International Dermatology Research, Inc. | Miami | Florida | 33144 | United States |
| Dermatology Specialists PSC | Louisville | Kentucky | 40202 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Helendale Dermatology & Medical Spa, LLC | Rochester | New York | 104609 | United States |
| Oregon Dermatology & Research Center | Portland | Oregon | 97210 | United States |
| Oregon Medical Research Center | Portland | Oregon | 97223 | United States |
| Arlington Research Center, Inc. | Arlington | Texas | 76011 | United States |
| DermResearch Inc. | Austin | Texas | 78759 | United States |
| J&S Studies, Inc. | College Station | Texas | 77845 | United States |
Participants applied Vehicle Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions. |
| COMPLETED |
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| NOT COMPLETED |
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The analysis was performed on Intent To Treat (ITT) Population that included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | CD2027 Ointment 3 mcg/g, Twice Daily | Participants applied 3 mcg/g CD2027 Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions. |
| BG001 | Vehicle Ointment, Twice Daily | Participants applied Vehicle Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Severity Score (TSS) of Target Lesion at Baseline and Week 4 | TSS comprised of the sum of an assessment of erythema, excoriation, exudation, lichenification and pruritus, each on a scale of 0 to 3 to give a maximum score of 15; 0 (best) and 3 (worst) indicated total possible minimum score was 0 and total possible maximum score was 15. Lower score meant improvement in condition and higher score indicated worsening of condition. | Intent To Treat (ITT) Population included all randomized participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 4 |
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| Secondary | Change From Baseline in Total Severity Score (TSS) for Individual Signs at Week 4 | TSS comprised of the sum of an assessment of erythema, excoriation, exudation, lichenification and pruritus, each on a scale of 0 to 3 to give a maximum score of 15; 0 (best) and 3 (Worst) indicated total possible minimum score was 0 and total possible maximum score was 15. Data for individual signs is reported in this outcome measure. Lower score meant improvement in condition and higher score indicated severity (worsening of condition) for each individual sign. Erythema was evaluated on a four point scale of 0 to 3 where (0=none, 1=mild, 2=moderate, 3=severe). Excoriation evaluated on a four point scale of 0 to 3 where (0=none, 1=mild, 2=moderate, 3=severe). Exudation was evaluated on a four point scale of 0 to 3 where (0=none, 1=mild, 2=moderate, 3=severe). Lichenification was evaluated on a four point scale of 0 to 3 where (0=none, 1=mild, 2=moderate, 3=severe). Pruritus was evaluated on a four point scale of 0 to 3 where (0=none, 1=mild, 2=moderate, 3=severe). | ITT Population included all randomized participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 4 |
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| Secondary | Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Failure From Baseline of Greater Than 1 Points Over Week 4 | IGA was an assessment scale used to determine severity of Atopic Dermatitis (AD) and clinical response to treatment on a 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of "0" or "1" and a failure from baseline of greater than (>1) points over 4 weeks were reported. | ITT Population included all randomized participants. | Posted | Count of Participants | Participants | Baseline, Week 1, Week 2, Week 3, Week 4 |
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| Secondary | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 1, 2, 3, 4 | The EASI score quantifies the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no eruption) to 6 (>90%-100% eruption). The total score was the sum of the four body-region scores, maximum=72, minimum=0, Higher scores indicated greater disease severity. | ITT Population included all randomized participants. | Posted | Mean | Standard Deviation | percent change | Baseline, Week1, Week2, Week 3, Week 4 |
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Up to 4 months.
Safety analysis set included all randomized participants who applied the study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CD2027 Ointment 3 mcg/g, Twice Daily | Participants applied 3 mcg/g CD2027 Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions. | 0 | 53 | 0 | 53 | 16 | 53 |
| EG001 | Vehicle Ointment, Twice Daily | Participants applied Vehicle Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions. | 0 | 49 | 0 | 49 | 8 | 49 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pruritis | General disorders | MedDRA v11.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v11.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA v11.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA v11.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA v11.0 | Non-systematic Assessment |
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| Prostate infection | Infections and infestations | MedDRA v11.0 | Non-systematic Assessment |
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| Vaginal infection | Infections and infestations | MedDRA v11.0 | Non-systematic Assessment |
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| Blood 1,25-dihydroxycholecalciferol increased | Investigations | MedDRA v11.0 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Non-systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Non-systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Non-systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Non-systematic Assessment |
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| Folliculitis | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Non-systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA v11.0 | Non-systematic Assessment |
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| Swollen tongue | Gastrointestinal disorders | MedDRA v11.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v11.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 8179615000 | 1 | Clinical.Studies@galderma.com |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| >=65 years |
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| Male |
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| Black |
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| Caucasian |
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| Hispanic |
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| OTHER |
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Participants applied Vehicle Ointment (up to 10 gram per application) topically, twice daily (at least 8 hours apart) over 4 weeks on atopic dermatitis lesions.
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| Participants |
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| Participants |
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