Trial Outcomes & Findings for Topical Roflumilast in Adults With Atopic Dermatitis (NCT NCT01856764)

Last Updated: 2017-02-01

Results Overview

Modified Local SCORAD is the sum of 5 individual indexes; erythema, edema/papulation, oozing/crusts, excoriations and lichenification scored on a 4 point scale, where 0=absent and 3=severe, with a total possible score of 15. Higher scores indicate greater severity.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Baseline and Day 15

Results posted on

2017-02-01

Participant Flow

Participants took part in the study at 3 centers in Germany from 10 June 2013 to 18 March 2014.

Participants with a historical diagnosis of Atopic Dermatitis were enrolled in 1 of 2 twice daily (BID) treatment groups.

Participant milestones

Participant milestones
Measure	0.5% Roflumilast Cream Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.	Vehicle Cream Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Topical Roflumilast in Adults With Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.5% Roflumilast Cream n=20 Participants Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.	Vehicle Cream n=20 Participants Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.	Total n=40 Participants Total of all reporting groups
Age, Continuous	32.7 Years STANDARD_DEVIATION 11.50 • n=5 Participants	36.5 Years STANDARD_DEVIATION 9.65 • n=7 Participants	34.6 Years STANDARD_DEVIATION 10.66 • n=5 Participants
Gender Female	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Gender Male	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Germany	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Height	177.3 centimeters STANDARD_DEVIATION 9.27 • n=5 Participants	174.9 centimeters STANDARD_DEVIATION 10.13 • n=7 Participants	176.1 centimeters STANDARD_DEVIATION 9.66 • n=5 Participants
Weight	81.72 kilograms STANDARD_DEVIATION 21.757 • n=5 Participants	78.31 kilograms STANDARD_DEVIATION 12.965 • n=7 Participants	80.02 kilograms STANDARD_DEVIATION 17.762 • n=5 Participants
Body Mass Index (BMI)	25.65 kg/m^2 STANDARD_DEVIATION 5.007 • n=5 Participants	25.59 kg/m^2 STANDARD_DEVIATION 3.477 • n=7 Participants	25.62 kg/m^2 STANDARD_DEVIATION 4.255 • n=5 Participants
Smoking Classificaiton Never smoked	5 participants n=5 Participants	8 participants n=7 Participants	13 participants n=5 Participants
Smoking Classificaiton Current smoker	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants
Smoking Classificaiton Ex-Smoker	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Female Reproductive Status Postmenopausal	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Female Reproductive Status Surgically sterile	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Female Reproductive Status Female of childbearing potential	9 participants n=5 Participants	11 participants n=7 Participants	20 participants n=5 Participants
Female Reproductive Status N/A (male participant)	11 participants n=5 Participants	9 participants n=7 Participants	20 participants n=5 Participants
Baseline Modified Local SCORing Atopic Dermatitis (SCORAD)	5.60 scores on a scale n=5 Participants	5.85 scores on a scale n=7 Participants	5.725 scores on a scale n=5 Participants
Baseline Transepidermal Water Loss (TEWL) Mean	41.47 g/m^2/hr n=5 Participants	41.57 g/m^2/hr n=7 Participants	41.52 g/m^2/hr n=5 Participants
Baseline Participant Assessment of Pruritis	5.05 scores on a scale n=5 Participants	5.00 scores on a scale n=7 Participants	5.025 scores on a scale n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Day 15

Population: All randomized participants who received at least one application of any double-blind study medication with a score at Day 15. One subject in the 0.5% Roflumilast group was missing Day 15 data.

Outcome measures

Outcome measures
Measure	0.5% Roflumilast Cream n=19 Participants Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.	Vehicle Cream n=20 Participants Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
Change From Baseline to Day 15 in Modified Local SCORing Atopic Dermatitis (SCORAD)	-2.30 Scores on a scale Standard Error 0.354	-1.75 Scores on a scale Standard Error 0.347

SECONDARY outcome

Timeframe: Baseline and Day 15

Diffusion of water through the skin is measured using a Tewameter. At each visit, 3 measurements are taken per treatment area (at 3 different areas of the target lesion). The TEWL value at each visit is the average of these measurements.

Outcome measures

Outcome measures
Measure	0.5% Roflumilast Cream n=19 Participants Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.	Vehicle Cream n=20 Participants Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
Change From Baseline to Day 15 in Transepidermal Water Loss (TEWL) Values	-18.60 g/m^2/hr Standard Error 2.467	-12.69 g/m^2/hr Standard Error 2.417

SECONDARY outcome

Timeframe: Baseline and Day 15

Severity of pruritus is assessed by the participants and recorded on a numeric scale ranging from 0 to 10, where 0 indicates the absence of the symptoms and 10 indicates the most severe symptoms.

Outcome measures

Outcome measures
Measure	0.5% Roflumilast Cream n=19 Participants Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.	Vehicle Cream n=20 Participants Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
Change From Baseline to Day 15 in Participants' Assessment of Pruritus	-3.05 Scores on a scale Standard Error 0.426	-1.50 Scores on a scale Standard Error 0.417

Adverse Events

0.5% Roflumilast Cream

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Vehicle Cream

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	0.5% Roflumilast Cream n=20 participants at risk Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.	Vehicle Cream n=20 participants at risk Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
General disorders Application Site Pain	5.0% 1/20 • Number of events 1 • From the time informed consent is signed through 7 days after the last dose of study drug (up to Day 22) The population consisted of all randomized participants. At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment	5.0% 1/20 • Number of events 1 • From the time informed consent is signed through 7 days after the last dose of study drug (up to Day 22) The population consisted of all randomized participants. At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment
Infections and infestations Nasopharyngitis	15.0% 3/20 • Number of events 3 • From the time informed consent is signed through 7 days after the last dose of study drug (up to Day 22) The population consisted of all randomized participants. At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment	0.00% 0/20 • From the time informed consent is signed through 7 days after the last dose of study drug (up to Day 22) The population consisted of all randomized participants. At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment
Investigations Gamma-glutamyltransferase increased	5.0% 1/20 • Number of events 1 • From the time informed consent is signed through 7 days after the last dose of study drug (up to Day 22) The population consisted of all randomized participants. At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment	0.00% 0/20 • From the time informed consent is signed through 7 days after the last dose of study drug (up to Day 22) The population consisted of all randomized participants. At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment
Investigations Alanine aminotransferase increased	5.0% 1/20 • Number of events 1 • From the time informed consent is signed through 7 days after the last dose of study drug (up to Day 22) The population consisted of all randomized participants. At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment	0.00% 0/20 • From the time informed consent is signed through 7 days after the last dose of study drug (up to Day 22) The population consisted of all randomized participants. At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 1/20 • Number of events 1 • From the time informed consent is signed through 7 days after the last dose of study drug (up to Day 22) The population consisted of all randomized participants. At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment	0.00% 0/20 • From the time informed consent is signed through 7 days after the last dose of study drug (up to Day 22) The population consisted of all randomized participants. At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment
Investigations Red blood cells urine	0.00% 0/20 • From the time informed consent is signed through 7 days after the last dose of study drug (up to Day 22) The population consisted of all randomized participants. At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment	5.0% 1/20 • Number of events 1 • From the time informed consent is signed through 7 days after the last dose of study drug (up to Day 22) The population consisted of all randomized participants. At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment
Investigations Blood creatine phosphokinase increased	0.00% 0/20 • From the time informed consent is signed through 7 days after the last dose of study drug (up to Day 22) The population consisted of all randomized participants. At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment	5.0% 1/20 • Number of events 1 • From the time informed consent is signed through 7 days after the last dose of study drug (up to Day 22) The population consisted of all randomized participants. At each visit, investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment

Additional Information

AstraZeneca Clinical Study Information Center

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
Publication restrictions are in place

Restriction type: OTHER