Trial Outcomes & Findings for Efficacy and Safety Study of CD2027 Ointment 3 Microgram Per Gram (mcg/g) Twice Daily Treatment for Adults With at Least Moderate Atopic Dermatitis (NCT NCT00919763)

NCT ID: NCT00919763

Last Updated: 2022-07-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

102 participants

Primary outcome timeframe

Baseline, Week 4

Results posted on

2022-07-19

Participant Flow

Participants took part in the study at 14 investigative sites in the United States from 21 May 2009 to 01 October 2009.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	53	49
Overall Study COMPLETED	41	45
Overall Study NOT COMPLETED	12	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Adverse Event	7	1
Overall Study Lost to Follow-up	1	0
Overall Study Protocol Violation	1	1
Overall Study Withdrawal by Subject	3	1
Overall Study Non-compliance	0	1

Baseline Characteristics

Efficacy and Safety Study of CD2027 Ointment 3 Microgram Per Gram (mcg/g) Twice Daily Treatment for Adults With at Least Moderate Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CD2027 Ointment 3 mcg/g, Twice Daily n=53 Participants 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 n=49 Participants 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.	Total n=102 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants	48 Participants n=7 Participants	98 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	38.3 years STANDARD_DEVIATION 14.9 • n=5 Participants	40.3 years STANDARD_DEVIATION 13.8 • n=7 Participants	39.3 years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	20 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	29 Participants n=7 Participants	54 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Race · Caucasian	27 Participants n=5 Participants	21 Participants n=7 Participants	48 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Race · OTHER	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	53 Participants n=5 Participants	49 Participants n=7 Participants	102 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: Intent To Treat (ITT) Population included all randomized participants.

Outcome measures

Outcome measures
Measure	CD2027 Ointment 3 mcg/g, Twice Daily n=53 Participants 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 n=49 Participants 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.
Total Severity Score (TSS) of Target Lesion at Baseline and Week 4 Baseline	7.62 score on a scale Standard Deviation 1.47	7.49 score on a scale Standard Deviation 1.53
Total Severity Score (TSS) of Target Lesion at Baseline and Week 4 Week 4	4.7 score on a scale Standard Deviation 2.6	4.6 score on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: ITT Population included all randomized participants.

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).

Outcome measures

Outcome measures
Measure	CD2027 Ointment 3 mcg/g, Twice Daily n=53 Participants 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 n=49 Participants 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.
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	-0.7 score on a scale Standard Deviation 0.7
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	-0.7 score on a scale Standard Deviation 0.8
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	-0.7 score on a scale Standard Deviation 0.7
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	-0.6 score on a scale Standard Deviation 0.8
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	-0.8 score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4

Population: ITT Population included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	CD2027 Ointment 3 mcg/g, Twice Daily n=53 Participants 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 n=49 Participants 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.
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	49 Participants
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	0 Participants
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	49 Participants
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	1 Participants
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	48 Participants
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	3 Participants
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	46 Participants
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	11 Participants
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	38 Participants
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	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week1, Week2, Week 3, Week 4

Population: ITT Population included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	CD2027 Ointment 3 mcg/g, Twice Daily n=53 Participants 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 n=49 Participants 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.
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	-16.2 percent change Standard Deviation 34.2
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	-26.7 percent change Standard Deviation 36.9
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	-33.2 percent change Standard Deviation 41.6
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	-41.4 percent change Standard Deviation 45.7

Adverse Events

CD2027 Ointment 3 mcg/g, Twice Daily

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Vehicle Ointment, Twice Daily

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Clinical Operations

Galderma

Phone: 8179615000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	CD2027 Ointment 3 mcg/g, Twice Daily n=53 participants at risk 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 n=49 participants at risk 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.
General disorders Application site pruritis	1.9% 1/53 • Number of events 1 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.	0.00% 0/49 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.
Hepatobiliary disorders Hyperbilirubinaemia	1.9% 1/53 • Number of events 1 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.	0.00% 0/49 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.
Infections and infestations Gastroenteritis	1.9% 1/53 • Number of events 1 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.	0.00% 0/49 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.
Infections and infestations Influenza	0.00% 0/53 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.	2.0% 1/49 • Number of events 1 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.
Infections and infestations Nasopharyngitis	0.00% 0/53 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.	2.0% 1/49 • Number of events 1 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.
Infections and infestations Prostate infection	0.00% 0/53 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.	2.0% 1/49 • Number of events 1 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.
Infections and infestations Vaginal infection	0.00% 0/53 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.	2.0% 1/49 • Number of events 1 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.
Investigations Blood 1,25-dihydroxycholecalciferol increased	9.4% 5/53 • Number of events 5 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.	0.00% 0/49 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.
Musculoskeletal and connective tissue disorders Back Pain	1.9% 1/53 • Number of events 1 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.	0.00% 0/49 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.
Musculoskeletal and connective tissue disorders Neck Pain	1.9% 1/53 • Number of events 1 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.	0.00% 0/49 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.
Skin and subcutaneous tissue disorders Dermatitis atopic	11.3% 6/53 • Number of events 6 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.	6.1% 3/49 • Number of events 3 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.
Skin and subcutaneous tissue disorders Dermatitis contact	1.9% 1/53 • Number of events 1 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.	0.00% 0/49 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.
Skin and subcutaneous tissue disorders Folliculitis	1.9% 1/53 • Number of events 1 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.	0.00% 0/49 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.
Skin and subcutaneous tissue disorders Skin irritation	1.9% 1/53 • Number of events 1 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.	2.0% 1/49 • Number of events 1 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.
Vascular disorders Hypertension	1.9% 1/53 • Number of events 1 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.	0.00% 0/49 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.
Gastrointestinal disorders Swollen tongue	0.00% 0/53 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.	2.0% 1/49 • Number of events 1 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.
Nervous system disorders Headache	0.00% 0/53 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.	2.0% 1/49 • Number of events 1 • Up to 4 months. Safety analysis set included all randomized participants who applied the study medication.