Trial Outcomes & Findings for Tolerance and Efficacy of Formulation 609580 20 Versus Formulation 609209 in Children With Atopic Dermatitis (NCT NCT00931411)

Results Overview

The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the changes in SCORAD at Day 7 and Day 42. It measures intensity of erythema/darkening, edema/papulation, oozing/crust, excoriation, lichenfinication/prurigo and dryness on a scale from 0-3 for a total of 18 points. This score is multiplided by 3.5 and added to 1/5 of the affected percent body surface area. The final score is added to the score from a 10-point pruritus visual analog scale (VAS) and a 10-point loss of sleep VAS. Best score is 0, worst is 103.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

73 participants

Primary outcome timeframe

7 , 42 days

Results posted on

2011-09-20

Participant Flow

Participant milestones

Participant milestones
Measure	Formulation 609580 20 Then 609209 Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. This is followed by the same application of formulation 609209 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.	Formulation 609209 Then 609580 20 Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. THis is followed by the same application of formulation 609580 20 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
First Intervention - 42 Days STARTED	35	38
First Intervention - 42 Days COMPLETED	31	35
First Intervention - 42 Days NOT COMPLETED	4	3
After Crossover - 14 Days (up to Day 56) STARTED	31	35
After Crossover - 14 Days (up to Day 56) COMPLETED	31	34
After Crossover - 14 Days (up to Day 56) NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Formulation 609580 20 Then 609209 Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. This is followed by the same application of formulation 609209 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.	Formulation 609209 Then 609580 20 Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. THis is followed by the same application of formulation 609580 20 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
First Intervention - 42 Days Adverse Event	2	3
First Intervention - 42 Days Lost to Follow-up	2	0
After Crossover - 14 Days (up to Day 56) Adverse Event	0	1

Baseline Characteristics

Tolerance and Efficacy of Formulation 609580 20 Versus Formulation 609209 in Children With Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Formulation 609580 20 Then 609209 n=35 Participants Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. This is followed by the same application of formulation 609209 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.	Formulation 609209 Then 609580 20 n=38 Participants Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. THis is followed by the same application of formulation 609580 20 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.	Total n=73 Participants Total of all reporting groups
Age, Categorical <=18 years	35 Participants n=5 Participants	38 Participants n=7 Participants	73 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	7.11 years STANDARD_DEVIATION 2.83 • n=5 Participants	6.66 years STANDARD_DEVIATION 2.36 • n=7 Participants	6.88 years STANDARD_DEVIATION 2.59 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	27 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	11 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment Canada	35 participants n=5 Participants	38 participants n=7 Participants	73 participants n=5 Participants
SCORAD - Score Atopic Dermatitis	21.5 Units on a scale STANDARD_DEVIATION 4.8 • n=5 Participants	21.2 Units on a scale STANDARD_DEVIATION 5.2 • n=7 Participants	21.3 Units on a scale STANDARD_DEVIATION 5.0 • n=5 Participants
Quality of Life Questionnaire	4.75 Units on a scale STANDARD_DEVIATION 10.2 • n=5 Participants	9.25 Units on a scale STANDARD_DEVIATION 12.2 • n=7 Participants	7.1 Units on a scale STANDARD_DEVIATION 11.4 • n=5 Participants

PRIMARY outcome

Timeframe: 7 , 42 days

Population: All subjects that had at least one evaluation after the Day 0 visit were included in the efficacy evaluations if their overall compliance was between 70 and 120%. Missing data were replaced using the last observation carried forward (LOCF) method. Two patients lost to follow-up and 5 less than 70% compliant were not included in this analysis.

The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the changes in SCORAD at Day 7 and Day 42. It measures intensity of erythema/darkening, edema/papulation, oozing/crust, excoriation, lichenfinication/prurigo and dryness on a scale from 0-3 for a total of 18 points. This score is multiplided by 3.5 and added to 1/5 of the affected percent body surface area. The final score is added to the score from a 10-point pruritus visual analog scale (VAS) and a 10-point loss of sleep VAS. Best score is 0, worst is 103.

Outcome measures

Outcome measures
Measure	Formulation 609580 20 n=31 Participants Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.	Formulation 609209 n=35 Participants Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
Mean Percent Change in SCORAD (Scoring Atopic Dermatitis) From Day 0 Day 7	-35.5 Percentage of change in SCORAD Standard Deviation 23.30	-49.72 Percentage of change in SCORAD Standard Deviation 24.62
Mean Percent Change in SCORAD (Scoring Atopic Dermatitis) From Day 0 Day 42	-56.56 Percentage of change in SCORAD Standard Deviation 36.92	-61.99 Percentage of change in SCORAD Standard Deviation 34.22

SECONDARY outcome

Timeframe: 7, 42 Days

Population: All subjects with all evaluations after the Day 0 visit were included in this evaluation if their overall compliance was \>70 and \<120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, one missing Day 7 value and 5 less than 70% compliant were not included in this analysis.

The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the global efficacy evaluation scale at Day 7 and Day 42 (by investigator). * 0 = worsening * 1 = No change * 2 = Mild Improvement * 3 = Moderate Improvement * 4 = Good Improvement * 5 = Excellent Improvement

Outcome measures

Outcome measures
Measure	Formulation 609580 20 n=30 Participants Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.	Formulation 609209 n=35 Participants Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
Change in Mean Global Efficacy (by Investigator). Day 7	3.23 Units on a scale Standard Deviation 1.22	3.48 Units on a scale Standard Deviation 1.22
Change in Mean Global Efficacy (by Investigator). Day 42	3.87 Units on a scale Standard Deviation 1.5	4.06 Units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 7, 42 days

Population: All subjects with all evaluations after the Day 0 visit were included in this evaluation if their overall compliance was \>70 and \<120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, two missing Day 7 value and 5 less than 70% compliant were not included in this analysis.

The efficacy of formulation 609580 20 to provide relief to children with atopic dermatitis compared to formulation 609209 as measured by the global efficacy evaluation scale at Day 7 and Day 42 (by parent). * 0 = worsening * 1 = No change * 2 = Mild Improvement * 3 = Moderate Improvement * 4 = Good Improvement * 5 = Excellent Improvement

Outcome measures

Outcome measures
Measure	Formulation 609580 20 n=30 Participants Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.	Formulation 609209 n=34 Participants Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
Change in Mean Global Efficacy (by Parent) Day 7	3.27 Units on a scale Standard Deviation 1.14	3.06 Units on a scale Standard Deviation 1.28
Change in Mean Global Efficacy (by Parent) Day 42	3.8 Units on a scale Standard Deviation 1.4	3.68 Units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 0, 42 days

Population: All subjects with at least one evaluation after the Day 0 visit were included in this evaluation if their overall compliance between 70 and 120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, and 5 less than 70% compliant were not included in this analysis.

The effect of formulation 609580 20 to improve quality of life compared to formulation 609209 as measured by changes in the quality of life questionnaire score from Day 0 to Day 42. Scale from -46 (worst) to 46 (best).

Outcome measures

Outcome measures
Measure	Formulation 609580 20 n=31 Participants Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.	Formulation 609209 n=35 Participants Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
Change in Mean Quality of Life	23.74 Units on a scale Standard Deviation 12.74	23.09 Units on a scale Standard Deviation 12.62

SECONDARY outcome

Timeframe: 0, 42 days

Population: All subjects with at least one evaluation after the Day 0 visit were included in the cosmetic evaluation if their overall compliance between 70 and 120%. Missing data were imputed using last observation carried forward (LOCF). Two patients lost to follow-up, and 5 less than 70% compliant were not included in this analysis.

The cosmetic acceptability of formulation 609580 20 compared to formulation 609209 as measured by the total score in the cosmetic acceptability questionnaire during the first 42 prior to the crossover. Scale from 44 (worst) to -44 (best).

Outcome measures

Outcome measures
Measure	Formulation 609580 20 n=31 Participants Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.	Formulation 609209 n=35 Participants Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
Change in Mean Cosmetic Acceptability Before Crossover	-19.4 Units on a scale Standard Deviation 10.4	-20.4 Units on a scale Standard Deviation 10.4

SECONDARY outcome

Timeframe: 14 days (Day 42 to Day 56 of the study)

Population: Subjects that had at least one evaluation after the Day 0 visit were in analysis if they had overall compliance between 70 and 120%. Missing data were imputed using last observation carried forward. Two patients lost to follow-up, 1 early term and 5 less than 70% compliant were not included in this analysis and participants swapped after crossover.

The cosmetic acceptability of formulation 609580 20 compared to formulation 609209 as measured by the total score in the cosmetic acceptability questionnaire during the 2 week period after the crossover. Scale from 44 (worst) to -44 (best). The 14 Days after the crossover is the same as Day 56 in the study.

Outcome measures

Outcome measures
Measure	Formulation 609580 20 n=34 Participants Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.	Formulation 609209 n=31 Participants Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
Change in Mean Cosmetic Acceptability After Crossover	-19.7 Units on a scale Standard Deviation 13.3	-17.8 Units on a scale Standard Deviation 14.4

SECONDARY outcome

Timeframe: 7, 42 days

Population: All subjects that had at least one evaluation after the Day 7 (no Day 0 visit for this parameter) visit were included in the efficacy evaluations. Missing data were replaced using the last observation carried forward (LOCF) method. Four patients had no Day 7 visit to carry forward and were not included in this analysis.

Tolerance of study products assessed by investigator at Day 7, 42. It was evaluated using the following scale: * 1\) Very good tolerance: no objective or subjective intolerance during the study * 2\) Good tolerance: very occasional symptoms, not resulting in cessation of applications, no objective sign * 3\) Average tolerance: repeated symptoms of intolerance, no cessation of application and no objective sign * 4\) Poor tolerance: symptoms requiring cessation of application, no objective sign * 5\) Very poor tolerance: objective signs of irritative or allergic dermatitis

Outcome measures

Outcome measures
Measure	Formulation 609580 20 n=34 Participants Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.	Formulation 609209 n=35 Participants Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
Change in Tolerance Before Crossover Day 7	1.35 Units on a scale Standard Deviation 0.60	1.60 Units on a scale Standard Deviation 0.77
Change in Tolerance Before Crossover Day 42	1.38 Units on a scale Standard Deviation 0.82	1.37 Units on a scale Standard Deviation 0.81

SECONDARY outcome

Timeframe: 14 Days (Day 42 to Day 56 of the study)

Population: All subjects that had at least one evaluation after Day 7 (no day 0 visit for this parameter) were included in the analysis. Missing data were replaced using the last observation carried forward method. The same patients as in outcome #7 did not have results to carry forward and were not included in analysis (subjects swapped after crossover).

Tolerance of study products assessed by investigator during the 2 weeks following the crossover (Day 56 of the study): * 1\) Very good tolerance: no objective or subjective intolerance during the study * 2\) Good tolerance: very occasional symptoms, not resulting in cessation of applications, no objective sign * 3\) Average tolerance: repeated symptoms of intolerance, no cessation of application and no objective sign * 4\) Poor tolerance: symptoms requiring cessation of application, no objective sign * 5\) Very poor tolerance: objective signs of irritative or allergic dermatitis

Outcome measures

Outcome measures
Measure	Formulation 609580 20 n=35 Participants Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.	Formulation 609209 n=34 Participants Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
Change in Mean Tolerance After Crossover	1.66 Units on a scale Standard Deviation 0.94	1.44 Units on a scale Standard Deviation 0.66

SECONDARY outcome

Timeframe: 56 days

Population: All subjects with an evaluation after the Day 42 visit were included in this evaluation if their overall compliance was between 70 and 120%. Two patients lost to follow-up, one with no Day 56 value and 5 less than 70% compliant were not included in this analysis.

Number of participants that preferred one formulation over the other. All patients started the study with one cream and crossed over to the other cream at Day 42 for another 14 days. Participants were asked which they prefered.

Outcome measures

Outcome measures
Measure	Formulation 609580 20 n=65 Participants Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.	Formulation 609209 Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
Preferred Formulation Formulation 609580 20	35 Participants	—
Preferred Formulation Formulation 605209	26 Participants	—
Preferred Formulation No Preference	4 Participants	—

Adverse Events

Formulation 609580 20

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Formulation 609209

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Formulation 609580 20 n=73 participants at risk Adverse events that were recorded before Day 42 for the group "Formulation 609580 20 then 609209" and recorded in the subsequent 2 weeks for the group "Formulation 609209 then 609580 20". Since this treatment was applied to both groups during this crossover study then the number of patients at risk for each treatment was the total of both groups.	Formulation 609209 n=73 participants at risk Adverse events that were recorded before Day 42 for the group "Formulation 609209 then 609580 20" and recorded in the subsequent 2 weeks for the group "Formulation 609580 20 then 609209". Since this treatment was applied to both groups during this crossover study then the number of patients at risk for each treatment was the total of both groups.
Infections and infestations Common cold	5.5% 4/73 • Number of events 4 • 56 days between the date of the first application and the final date of the study regardless of their compliance or their completion of the study.	11.0% 8/73 • Number of events 8 • 56 days between the date of the first application and the final date of the study regardless of their compliance or their completion of the study.
Skin and subcutaneous tissue disorders Pruritus	5.5% 4/73 • Number of events 4 • 56 days between the date of the first application and the final date of the study regardless of their compliance or their completion of the study.	5.5% 4/73 • Number of events 4 • 56 days between the date of the first application and the final date of the study regardless of their compliance or their completion of the study.

Additional Information

Annie Levesque

Innovaderm Research

Phone: 514-521-4285

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60