Atopic Dermatitis
Conditions
Keywords
Dermatitis, Atopic
Brief summary
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.
Interventions
DRUGCD2027 Ointment 3 mcg/g, twice daily
Topical Ointment
DRUGVehicle Ointment, twice daily
Topical Ointment
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female participant, 18 years of age or older * Clinical diagnosis of atopic dermatitis according to Hanifin and Rajka criteria, of at least moderate intensity according to Investigator Global Assessment (IGA greater or equal to 3) * Body surface affected by the disease between 5% and 20% of total BSA, based on Rule of Nine's, excluding Head/Neck * At least one area (Target Lesion) which was representative of the participant's disease state, was not located on the hands, feet or genitalia, measures at least 10 cm\^2, presented a Total Severity Score of at least 6/15 (total severity score defined as the sum of Erythema, Excoriation, Papulation/Induration, Oozing/Crusting and Lichenification) with oozing/crusting severity at most 1
Exclusion criteria
* The participant had albumin-adjusted calcium above the upper normal range from screening evaluation * The participant had history/signs/symptoms suggestive of an abnormality of calcium homeostasis (such as hyperparathyroidism, Paget's disease, adrenal insufficiency, hyperthyroidism) * The participant had signs/symptoms of urinary stones or has a history of urinary stones within the past 5 years prior to the Screening Visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Severity Score (TSS) of Target Lesion at Baseline and Week 4 | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Severity Score (TSS) for Individual Signs at Week 4 | Baseline, 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). |
| 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 | Baseline, Week 1, Week 2, Week 3, 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. |
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 1, 2, 3, 4 | Baseline, Week1, Week2, Week 3, Week 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. |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 14 investigative sites in the United States from 21 May 2009 to 01 October 2009.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 53 |
| 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. | 49 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Non-compliance | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | CD2027 Ointment 3 mcg/g, Twice Daily | Vehicle Ointment, Twice Daily | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 48 Participants | 98 Participants |
| Age, Continuous | 38.3 years STANDARD_DEVIATION 14.9 | 40.3 years STANDARD_DEVIATION 13.8 | 39.3 years STANDARD_DEVIATION 14.3 |
| Race/Ethnicity, Customized Race Asian | 4 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Race Black | 5 Participants | 10 Participants | 15 Participants |
| Race/Ethnicity, Customized Race Caucasian | 27 Participants | 21 Participants | 48 Participants |
| Race/Ethnicity, Customized Race Hispanic | 15 Participants | 10 Participants | 25 Participants |
| Race/Ethnicity, Customized Race OTHER | 2 Participants | 3 Participants | 5 Participants |
| Region of Enrollment United States | 53 Participants | 49 Participants | 102 Participants |
| Sex: Female, Male Female | 28 Participants | 20 Participants | 48 Participants |
| Sex: Female, Male Male | 25 Participants | 29 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 49 |
| other Total, other adverse events | 16 / 53 | 8 / 49 |
| serious Total, serious adverse events | 0 / 53 | 0 / 49 |
Outcome results
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.
Time frame: Baseline, Week 4
Population: Intent To Treat (ITT) Population included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD2027 Ointment 3 mcg/g, Twice Daily | Total Severity Score (TSS) of Target Lesion at Baseline and Week 4 | Baseline | 7.62 score on a scale | Standard Deviation 1.47 |
| CD2027 Ointment 3 mcg/g, Twice Daily | Total Severity Score (TSS) of Target Lesion at Baseline and Week 4 | Week 4 | 4.7 score on a scale | Standard Deviation 2.6 |
| Vehicle Ointment, Twice Daily | Total Severity Score (TSS) of Target Lesion at Baseline and Week 4 | Baseline | 7.49 score on a scale | Standard Deviation 1.53 |
| Vehicle Ointment, Twice Daily | Total Severity Score (TSS) of Target Lesion at Baseline and Week 4 | Week 4 | 4.6 score on a scale | Standard Deviation 3.2 |
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).
Time frame: Baseline, Week 4
Population: ITT Population included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD2027 Ointment 3 mcg/g, Twice Daily | Change From Baseline in Total Severity Score (TSS) for Individual Signs at Week 4 | Induration/Papulation | -0.7 score on a scale | Standard Deviation 0.9 |
| CD2027 Ointment 3 mcg/g, Twice Daily | Change From Baseline in Total Severity Score (TSS) for Individual Signs at Week 4 | Lichenification | -0.5 score on a scale | Standard Deviation 0.7 |
| CD2027 Ointment 3 mcg/g, Twice Daily | Change From Baseline in Total Severity Score (TSS) for Individual Signs at Week 4 | Excoriation | -0.8 score on a scale | Standard Deviation 0.9 |
| CD2027 Ointment 3 mcg/g, Twice Daily | Change From Baseline in Total Severity Score (TSS) for Individual Signs at Week 4 | Pruritus | -0.9 score on a scale | Standard Deviation 1.1 |
| CD2027 Ointment 3 mcg/g, Twice Daily | Change From Baseline in Total Severity Score (TSS) for Individual Signs at Week 4 | Erythema | -0.7 score on a scale | Standard Deviation 0.9 |
| Vehicle Ointment, Twice Daily | Change From Baseline in Total Severity Score (TSS) for Individual Signs at Week 4 | Pruritus | -0.8 score on a scale | Standard Deviation 1.2 |
| Vehicle Ointment, Twice Daily | Change From Baseline in Total Severity Score (TSS) for Individual Signs at Week 4 | Erythema | -0.7 score on a scale | Standard Deviation 0.7 |
| Vehicle Ointment, Twice Daily | Change From Baseline in Total Severity Score (TSS) for Individual Signs at Week 4 | Induration/Papulation | -0.7 score on a scale | Standard Deviation 0.8 |
| Vehicle Ointment, Twice Daily | Change From Baseline in Total Severity Score (TSS) for Individual Signs at Week 4 | Excoriation | -0.7 score on a scale | Standard Deviation 0.7 |
| Vehicle Ointment, Twice Daily | Change From Baseline in Total Severity Score (TSS) for Individual Signs at Week 4 | Lichenification | -0.6 score on a scale | Standard Deviation 0.8 |
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.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4
Population: ITT Population included all randomized participants.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| CD2027 Ointment 3 mcg/g, Twice Daily | 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 | Baseline | Success (IGA=0 or 1) | 0 Participants |
| CD2027 Ointment 3 mcg/g, Twice Daily | 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 | Baseline | Failure (IGA>1) | 53 Participants |
| CD2027 Ointment 3 mcg/g, Twice Daily | 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 | Week 1 | Success (IGA=0 or 1) | 2 Participants |
| CD2027 Ointment 3 mcg/g, Twice Daily | 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 | Week 1 | Failure (IGA>1) | 51 Participants |
| CD2027 Ointment 3 mcg/g, Twice Daily | 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 | Week 2 | Success (IGA=0 or 1) | 3 Participants |
| CD2027 Ointment 3 mcg/g, Twice Daily | 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 | Week 2 | Failure (IGA>1) | 50 Participants |
| CD2027 Ointment 3 mcg/g, Twice Daily | 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 | Week 3 | Success (IGA=0 or 1) | 5 Participants |
| CD2027 Ointment 3 mcg/g, Twice Daily | 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 | Week 3 | Failure (IGA>1) | 48 Participants |
| CD2027 Ointment 3 mcg/g, Twice Daily | 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 | Week 4 | Success (IGA=0 or 1) | 10 Participants |
| CD2027 Ointment 3 mcg/g, Twice Daily | 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 | Week 4 | Failure (IGA>1) | 43 Participants |
| Vehicle Ointment, Twice Daily | 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 | Week 3 | Failure (IGA>1) | 46 Participants |
| Vehicle Ointment, Twice Daily | 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 | Baseline | Success (IGA=0 or 1) | 0 Participants |
| Vehicle Ointment, Twice Daily | 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 | Week 2 | Failure (IGA>1) | 48 Participants |
| Vehicle Ointment, Twice Daily | 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 | Baseline | Failure (IGA>1) | 49 Participants |
| Vehicle Ointment, Twice Daily | 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 | Week 4 | Failure (IGA>1) | 38 Participants |
| Vehicle Ointment, Twice Daily | 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 | Week 1 | Success (IGA=0 or 1) | 0 Participants |
| Vehicle Ointment, Twice Daily | 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 | Week 3 | Success (IGA=0 or 1) | 3 Participants |
| Vehicle Ointment, Twice Daily | 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 | Week 1 | Failure (IGA>1) | 49 Participants |
| Vehicle Ointment, Twice Daily | 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 | Week 4 | Success (IGA=0 or 1) | 11 Participants |
| Vehicle Ointment, Twice Daily | 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 | Week 2 | Success (IGA=0 or 1) | 1 Participants |
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.
Time frame: Baseline, Week1, Week2, Week 3, Week 4
Population: ITT Population included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD2027 Ointment 3 mcg/g, Twice Daily | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 1, 2, 3, 4 | Week 1 | -10.0 percent change | Standard Deviation 34.2 |
| CD2027 Ointment 3 mcg/g, Twice Daily | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 1, 2, 3, 4 | Week 2 | -21.3 percent change | Standard Deviation 51.3 |
| CD2027 Ointment 3 mcg/g, Twice Daily | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 1, 2, 3, 4 | Week 3 | -28.7 percent change | Standard Deviation 63.3 |
| CD2027 Ointment 3 mcg/g, Twice Daily | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 1, 2, 3, 4 | Week 4 | -29.6 percent change | Standard Deviation 69.9 |
| Vehicle Ointment, Twice Daily | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 1, 2, 3, 4 | Week 4 | -41.4 percent change | Standard Deviation 45.7 |
| Vehicle Ointment, Twice Daily | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 1, 2, 3, 4 | Week 1 | -16.2 percent change | Standard Deviation 34.2 |
| Vehicle Ointment, Twice Daily | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 1, 2, 3, 4 | Week 3 | -33.2 percent change | Standard Deviation 41.6 |
| Vehicle Ointment, Twice Daily | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 1, 2, 3, 4 | Week 2 | -26.7 percent change | Standard Deviation 36.9 |