Trial Outcomes & Findings for Study of 0417 Ointment in the Treatment of Atopic Dermatitis (NCT NCT01139450)

NCT ID: NCT01139450

Last Updated: 2014-10-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 899 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2014-10-09

Participant Flow

Participant milestones

Measure	Test Test product that contains the active pharmaceutical ingredient Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks	Reference Reference product that contains the active pharmaceutical ingredient Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks	Vehicle Placebo that contains no active pharmaceutical ingredient Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks
Overall Study STARTED	302	297	300
Overall Study COMPLETED	275	272	262
Overall Study NOT COMPLETED	27	25	38

Reasons for withdrawal

Measure	Test Test product that contains the active pharmaceutical ingredient Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks	Reference Reference product that contains the active pharmaceutical ingredient Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks	Vehicle Placebo that contains no active pharmaceutical ingredient Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks
Overall Study Withdrawal by Subject	7	10	13
Overall Study Lack of Efficacy	3	1	8
Overall Study Protocol Violation	6	5	2
Overall Study Lost to Follow-up	9	7	11
Overall Study Administrative	0	0	1
Overall Study Adverse Event	2	2	3

Baseline Characteristics

Study of 0417 Ointment in the Treatment of Atopic Dermatitis

Baseline characteristics by cohort

Measure	Test n=302 Participants Test product that contains the active pharmaceutical ingredient Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks	Reference n=297 Participants Reference product that contains the active pharmaceutical ingredient Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks	Vehicle n=300 Participants Placebo that contains no active pharmaceutical ingredient Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks	Total n=899 Participants Total of all reporting groups
Age, Customized Age, Years	27.74 years STANDARD_DEVIATION 18.11 • n=5 Participants	28.8 years STANDARD_DEVIATION 18.99 • n=7 Participants	27.6 years STANDARD_DEVIATION 17.34 • n=5 Participants	28.0 years STANDARD_DEVIATION 18.14 • n=4 Participants
Sex: Female, Male Female	186 Participants n=5 Participants	194 Participants n=7 Participants	186 Participants n=5 Participants	566 Participants n=4 Participants
Sex: Female, Male Male	116 Participants n=5 Participants	103 Participants n=7 Participants	114 Participants n=5 Participants	333 Participants n=4 Participants
Region of Enrollment United States	280 participants n=5 Participants	275 participants n=7 Participants	279 participants n=5 Participants	834 participants n=4 Participants
Region of Enrollment Central America	22 participants n=5 Participants	22 participants n=7 Participants	21 participants n=5 Participants	65 participants n=4 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	Test n=226 Participants Test product that contains the active pharmaceutical ingredient Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks	Reference n=238 Participants Reference product that contains the active pharmaceutical ingredient Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks	Vehicle n=228 Participants Placebo that contains no active pharmaceutical ingredient Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks
Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment	123 participants	130 participants	86 participants

SECONDARY outcome

Timeframe: Baseline, 4 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 4 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 4 weeks

Outcome measures

Outcome data not reported

Adverse Events

Test

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Reference

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Vehicle

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Test n=302 participants at risk Test product that contains the active pharmaceutical ingredient Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks	Reference n=297 participants at risk Reference product that contains the active pharmaceutical ingredient Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks	Vehicle n=300 participants at risk Placebo that contains no active pharmaceutical ingredient Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks
Infections and infestations Moderate Influenza	0.33% 1/302	0.00% 0/297	0.00% 0/300
Cardiac disorders Severe Angina Pectoris	0.00% 0/302	0.00% 0/297	0.33% 1/300
Reproductive system and breast disorders Ovarian Cyst	0.33% 1/302	0.00% 0/297	0.00% 0/300

Other adverse events

Measure	Test n=302 participants at risk Test product that contains the active pharmaceutical ingredient Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks	Reference n=297 participants at risk Reference product that contains the active pharmaceutical ingredient Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks	Vehicle n=300 participants at risk Placebo that contains no active pharmaceutical ingredient Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks
General disorders Application site irritation	4.0% 12/302	3.7% 11/297	2.7% 8/300
Skin and subcutaneous tissue disorders Dermatitis atopic	1.7% 5/302	0.34% 1/297	4.0% 12/300

Additional Information

Angela C. Kaplan

Fougera Pharmaceuticals Inc.

Phone: 631-659-2256

Email: angela.kaplan@sandoz.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER