Trial Outcomes & Findings for Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis (NCT NCT03107611)
NCT ID: NCT03107611
Last Updated: 2022-03-07
Results Overview
Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
654 participants
Primary outcome timeframe
Day 15
Results posted on
2022-03-07
Participant Flow
Participant milestones
| Measure |
Test
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Pimecrolimus Cream, 1%
|
Reference Standard
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Pimecrolimus Cream, 1%
|
Placebo
Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days
Placebo Cream
|
|---|---|---|---|
|
Overall Study
STARTED
|
217
|
216
|
221
|
|
Overall Study
Dosed
|
215
|
214
|
220
|
|
Overall Study
COMPLETED
|
210
|
212
|
212
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
9
|
Reasons for withdrawal
| Measure |
Test
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Pimecrolimus Cream, 1%
|
Reference Standard
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Pimecrolimus Cream, 1%
|
Placebo
Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days
Placebo Cream
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
3
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Worsening signs/symptoms
|
2
|
1
|
2
|
Baseline Characteristics
Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Test
n=215 Participants
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Pimecrolimus Cream, 1%
|
Reference Standard
n=214 Participants
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Pimecrolimus Cream, 1%
|
Placebo
n=220 Participants
Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days
Placebo Cream
|
Total
n=649 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.0 years
STANDARD_DEVIATION 20.2 • n=5 Participants
|
34.2 years
STANDARD_DEVIATION 18.9 • n=7 Participants
|
34.9 years
STANDARD_DEVIATION 21.6 • n=5 Participants
|
35.4 years
STANDARD_DEVIATION 20.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
404 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
245 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
127 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
378 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
88 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
271 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
98 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
284 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
115 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
350 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Investigator's Global Assessement of Severity
Mild
|
90 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
295 Participants
n=4 Participants
|
|
Investigator's Global Assessement of Severity
Moderate
|
125 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
354 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 15Population: Modified ITT (Intent-to-treat) sample
Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting
Outcome measures
| Measure |
Test
n=212 Participants
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Pimecrolimus Cream, 1%
|
Reference Standard
n=212 Participants
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Pimecrolimus Cream, 1%
|
Placebo
n=215 Participants
Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days
Placebo Cream
|
|---|---|---|---|
|
Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1])
|
108 Participants
|
115 Participants
|
98 Participants
|
PRIMARY outcome
Timeframe: Day 15Population: PP (per protocol) sample
Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting
Outcome measures
| Measure |
Test
n=201 Participants
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Pimecrolimus Cream, 1%
|
Reference Standard
n=205 Participants
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Pimecrolimus Cream, 1%
|
Placebo
n=203 Participants
Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days
Placebo Cream
|
|---|---|---|---|
|
Proportion of Per Protocol Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1])
|
105 Participants
|
113 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: Day 15Population: PP sample
Erythema, induration/papulation, lichenification and pruritus
Outcome measures
| Measure |
Test
n=201 Participants
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Pimecrolimus Cream, 1%
|
Reference Standard
n=205 Participants
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Pimecrolimus Cream, 1%
|
Placebo
n=203 Participants
Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days
Placebo Cream
|
|---|---|---|---|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Head & Neck · 3 = Worsen by 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Head & Neck · 2 = Worsen by 2
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Head & Neck · 1 = Worsen by 1
|
2 Participants
|
5 Participants
|
4 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Head & Neck · 0 = No change
|
121 Participants
|
118 Participants
|
135 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Head & Neck · -1 = Improve by 1
|
51 Participants
|
50 Participants
|
48 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Head & Neck · -2 = Improve by 2
|
24 Participants
|
30 Participants
|
15 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Head & Neck · -3 = Improve by 3
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Trunk · 3 = Worsen by 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Trunk · 2 = Worsen by 2
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Trunk · 1 = Worsen by 1
|
3 Participants
|
4 Participants
|
6 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Trunk · 0 = No change
|
106 Participants
|
113 Participants
|
116 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Trunk · -1 = Improve by 1
|
56 Participants
|
57 Participants
|
50 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Trunk · -2 = Improve by 2
|
35 Participants
|
30 Participants
|
30 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Trunk · -3 = Improve by 3
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Upper Limbs · 3 = Worsen by 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Upper Limbs · 2 = Worsen by 2
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Upper Limbs · 1 = Worsen by 1
|
4 Participants
|
1 Participants
|
7 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Upper Limbs · 0 = No change
|
71 Participants
|
80 Participants
|
85 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Upper Limbs · -1 = Improve by 1
|
76 Participants
|
91 Participants
|
76 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Upper Limbs · -2 = Improve by 2
|
49 Participants
|
33 Participants
|
33 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Upper Limbs · -3 = Improve by 3
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Lower Limbs · 3 = Worsen by 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Lower Limbs · 2 = Worsen by 2
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Lower Limbs · 1 = Worsen by 1
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Lower Limbs · 0 = No change
|
101 Participants
|
109 Participants
|
106 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Lower Limbs · -1 = Improve by 1
|
64 Participants
|
62 Participants
|
61 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Lower Limbs · -2 = Improve by 2
|
34 Participants
|
30 Participants
|
30 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Erythema - Lower Limbs · -3 = Improve by 3
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Head & Neck · 3 = Worsen by 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Head & Neck · 2 = Worsen by 2
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Head & Neck · 1 = Worsen by 1
|
0 Participants
|
5 Participants
|
3 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Head & Neck · 0 = No change
|
118 Participants
|
117 Participants
|
135 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Head & Neck · -1 = Improve by 1
|
59 Participants
|
57 Participants
|
51 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Head & Neck · -2 = Improve by 2
|
22 Participants
|
23 Participants
|
14 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Head & Neck · -3 = Improve by 3
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Trunk · 3 = Worsen by 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Trunk · 2 = Worsen by 2
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Trunk · 1 = Worsen by 1
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Trunk · 0 = No change
|
103 Participants
|
110 Participants
|
108 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Trunk · -1 = Improve by 1
|
62 Participants
|
57 Participants
|
55 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Trunk · -2 = Improve by 2
|
31 Participants
|
33 Participants
|
34 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Trunk · -3 = Improve by 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Upper Limbs · 3 = Worsen by 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Upper Limbs · 2 = Worsen by 2
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Upper Limbs · 1 = Worsen by 1
|
4 Participants
|
5 Participants
|
6 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Upper Limbs · 0 = No change
|
75 Participants
|
79 Participants
|
88 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Upper Limbs · -1 = Improve by 1
|
83 Participants
|
83 Participants
|
81 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Upper Limbs · -2 = Improve by 2
|
39 Participants
|
35 Participants
|
26 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Upper Limbs · -3 = Improve by 3
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Lower Limbs · 3 = Worsen by 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Lower Limbs · 2 = Worsen by 2
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Lower Limbs · 1 = Worsen by 1
|
5 Participants
|
2 Participants
|
6 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Lower Limbs · 0 = No change
|
100 Participants
|
100 Participants
|
116 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Lower Limbs · -1 = Improve by 1
|
71 Participants
|
81 Participants
|
57 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Lower Limbs · -2 = Improve by 2
|
24 Participants
|
21 Participants
|
23 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Induration/Papulation - Lower Limbs · -3 = Improve by 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Head & Neck · 3 = Worsen by 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Head & Neck · 2 = Worsen by 2
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Head & Neck · 1 = Worsen by 1
|
5 Participants
|
5 Participants
|
2 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Head & Neck · 0 = No change
|
131 Participants
|
137 Participants
|
151 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Head & Neck · -1 = Improve by 1
|
47 Participants
|
41 Participants
|
42 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Head & Neck · -2 = Improve by 2
|
17 Participants
|
20 Participants
|
7 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Head & Neck · -3 = Improve by 3
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Trunk · 3 = Worsen by 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Trunk · 2 = Worsen by 2
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Trunk · 1 = Worsen by 1
|
4 Participants
|
6 Participants
|
6 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Trunk · 0 = No change
|
114 Participants
|
126 Participants
|
127 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Trunk · -1 = Improve by 1
|
59 Participants
|
50 Participants
|
50 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Trunk · -2 = Improve by 2
|
24 Participants
|
23 Participants
|
17 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Trunk · -3 = Improve by 3
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Upper Limbs · 3 = Worsen by 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Upper Limbs · 2 = Worsen by 2
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Upper Limbs · 1 = Worsen by 1
|
7 Participants
|
6 Participants
|
12 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Upper Limbs · 0 = No change
|
93 Participants
|
93 Participants
|
98 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Upper Limbs · -1 = Improve by 1
|
72 Participants
|
83 Participants
|
65 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Upper Limbs · -2 = Improve by 2
|
29 Participants
|
18 Participants
|
26 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Upper Limbs · -3 = Improve by 3
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Lower Limbs · 3 = Worsen by 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Lower Limbs · 2 = Worsen by 2
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Lower Limbs · 1 = Worsen by 1
|
6 Participants
|
2 Participants
|
5 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Lower Limbs · 0 = No change
|
126 Participants
|
113 Participants
|
126 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Lower Limbs · -1 = Improve by 1
|
54 Participants
|
71 Participants
|
52 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Lower Limbs · -2 = Improve by 2
|
13 Participants
|
16 Participants
|
18 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Lichenification - Lower Limbs · -3 = Improve by 3
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Pruritus · 3 = Worsen by 3
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Pruritus · 2 = Worsen by 2
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Pruritus · 1 = Worsen by 1
|
4 Participants
|
5 Participants
|
10 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Pruritus · 0 = No change
|
42 Participants
|
41 Participants
|
59 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Pruritus · -1 = Improve by 1
|
76 Participants
|
78 Participants
|
82 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Pruritus · -2 = Improve by 2
|
73 Participants
|
71 Participants
|
49 Participants
|
|
Change in Severity of Four Individual Signs and Symptoms
Pruritus · -3 = Improve by 3
|
4 Participants
|
8 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 15Population: Safety with data for this parameter
Dryness, burning/stinging, erosion, edema, and pain
Outcome measures
| Measure |
Test
n=214 Participants
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Pimecrolimus Cream, 1%
|
Reference Standard
n=213 Participants
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Pimecrolimus Cream, 1%
|
Placebo
n=217 Participants
Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days
Placebo Cream
|
|---|---|---|---|
|
Evaluation of Application Site Reactions
Pain · Moderate
|
4 Participants
|
2 Participants
|
7 Participants
|
|
Evaluation of Application Site Reactions
Dryness · None
|
121 Participants
|
126 Participants
|
103 Participants
|
|
Evaluation of Application Site Reactions
Dryness · Mild
|
64 Participants
|
63 Participants
|
76 Participants
|
|
Evaluation of Application Site Reactions
Dryness · Moderate
|
23 Participants
|
21 Participants
|
33 Participants
|
|
Evaluation of Application Site Reactions
Dryness · Severe
|
6 Participants
|
3 Participants
|
5 Participants
|
|
Evaluation of Application Site Reactions
Stinging/Burning · None
|
180 Participants
|
171 Participants
|
172 Participants
|
|
Evaluation of Application Site Reactions
Stinging/Burning · Mild
|
23 Participants
|
30 Participants
|
28 Participants
|
|
Evaluation of Application Site Reactions
Stinging/Burning · Moderate
|
11 Participants
|
11 Participants
|
14 Participants
|
|
Evaluation of Application Site Reactions
Stinging/Burning · Severe
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Evaluation of Application Site Reactions
Erosion · None
|
190 Participants
|
187 Participants
|
190 Participants
|
|
Evaluation of Application Site Reactions
Erosion · Mild
|
14 Participants
|
19 Participants
|
18 Participants
|
|
Evaluation of Application Site Reactions
Erosion · Moderate
|
8 Participants
|
7 Participants
|
9 Participants
|
|
Evaluation of Application Site Reactions
Erosion · Severe
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Evaluation of Application Site Reactions
Edema · None
|
196 Participants
|
194 Participants
|
193 Participants
|
|
Evaluation of Application Site Reactions
Edema · Mild
|
14 Participants
|
13 Participants
|
17 Participants
|
|
Evaluation of Application Site Reactions
Edema · Moderate
|
4 Participants
|
6 Participants
|
7 Participants
|
|
Evaluation of Application Site Reactions
Edema · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Evaluation of Application Site Reactions
Pain · None
|
192 Participants
|
195 Participants
|
197 Participants
|
|
Evaluation of Application Site Reactions
Pain · Mild
|
18 Participants
|
16 Participants
|
12 Participants
|
|
Evaluation of Application Site Reactions
Pain · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Test
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reference Standard
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prasanna C Ganapathi, Clinical Sciences Program Lead
Mylan Pharmaceuticals Pvt Ltd
Phone: +91 9148448200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The publication rights for the data generated rests with the sponsor. The site retains the right to use such data or results for its own publication only upon getting the written approval from the sponsor, only after the first publication of such data by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER