Trial Outcomes & Findings for Pimecrolimus Cream for Oral Lichen Planus (NCT NCT00297037)

NCT ID: NCT00297037

Last Updated: 2012-10-17

Results Overview

The primary efficacy variable was the change in the Investigator's Global Assessment of the overall severity of disease from baseline to week 6. Scale is 0-4. 0 is no disease. 4 is worst disease. Minimum score is 0. Maximum score is 4. Measurments were completed day 0, week 1, week 2, week 4, and week 6. Scores are listed at baseline (day 0) and end of study (week 6).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: 0, 1, 2, 4, 6 weeks
• Results posted on: 2012-10-17

Participant Flow

Participant milestones

Measure	Pimecrolimus 1% Cream 0.25 grams of pimecrolimus 1% cream applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes	Vehicle Cream 0.25 grams of vehicle cream (identical in composition and appearance to pimecrolimus 1% cream without active product) applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
Overall Study STARTED	10	11
Overall Study COMPLETED	8	11
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Pimecrolimus 1% Cream 0.25 grams of pimecrolimus 1% cream applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes	Vehicle Cream 0.25 grams of vehicle cream (identical in composition and appearance to pimecrolimus 1% cream without active product) applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Pimecrolimus Cream for Oral Lichen Planus

Baseline characteristics by cohort

Measure	Pimecrolimus 1% Cream n=10 Participants 0.25 grams of pimecrolimus 1% cream applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes	Vehicle Cream n=11 Participants 0.25 grams of vehicle cream (identical in composition and appearance to pimecrolimus 1% cream without active product) applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes	Total n=21 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	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0, 1, 2, 4, 6 weeks

Population: ITT using last observation carried forward for missing data

The primary efficacy variable was the change in the Investigator's Global Assessment of the overall severity of disease from baseline to week 6. Scale is 0-4. 0 is no disease. 4 is worst disease. Minimum score is 0. Maximum score is 4. Measurments were completed day 0, week 1, week 2, week 4, and week 6. Scores are listed at baseline (day 0) and end of study (week 6).

Outcome measures

Measure	Pimecrolimus Cream n=10 Participants "During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."	Vehicle Cream n=11 Participants "During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
The Primary Efficacy Variable Was the Change in the Investigator's Global Assessment of the Overall Severity of Disease From Baseline to Week 6. baseline	2.4 units on a scale Interval 2.0 to 4.0	2.45 units on a scale Interval 1.0 to 3.0
The Primary Efficacy Variable Was the Change in the Investigator's Global Assessment of the Overall Severity of Disease From Baseline to Week 6. week 6	1.6 units on a scale Interval 0.0 to 2.0	2.27 units on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: 0, 1, 2, 4, 6 weeks

The secondary efficacy variables were change in the size of the target erosion, erythema and assessment of spontaneous pain on a visual analog scale (0-10). The scale used to measure erythema is 0-3. 0 is no erythema, 1 is mild erythema, 2 is moderate erythema, and 3 is severe erythema. Minimum score is 0. Maximum score is 3. Spontaneous pain was scored on a scale of 0-10 (0 no pain, 10 severe pain). Measurments were completed day 0, week 1, week 2, week 4, and week 6. Scores are listed at baseline (day 0) and end of study (week 6).

Outcome measures

Measure	Pimecrolimus Cream n=10 Participants "During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."	Vehicle Cream n=11 Participants "During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
The Secondary Efficacy Variables Was Changes Erythema and Assessment of Spontaneous Pain on a Visual Analog Scale (0-10). mean erythema baseline	2 units on a scale Interval 0.0 to 3.0	2 units on a scale Interval 0.0 to 3.0
The Secondary Efficacy Variables Was Changes Erythema and Assessment of Spontaneous Pain on a Visual Analog Scale (0-10). mean erythema week 6	1 units on a scale Interval 0.0 to 2.0	1 units on a scale Interval 0.0 to 2.0
The Secondary Efficacy Variables Was Changes Erythema and Assessment of Spontaneous Pain on a Visual Analog Scale (0-10). mean pain baseline	3 units on a scale Interval 0.0 to 7.0	4 units on a scale Interval 0.0 to 8.0
The Secondary Efficacy Variables Was Changes Erythema and Assessment of Spontaneous Pain on a Visual Analog Scale (0-10). mean pain week 6	2 units on a scale Interval 0.0 to 5.0	3 units on a scale Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: 0, 1, 2, 4, 6 weeks

Secondary outcome variable was change in size of the target erosion in millimeters from baseline compared to week 6.

Outcome measures

Measure	Pimecrolimus Cream n=10 Participants "During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."	Vehicle Cream n=11 Participants "During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
The Secondary Efficacy Variable Was Change in the Size of a Target Erosion in Millimeters. mean erosion baseline	11 mm Interval 1.0 to 25.0	33 mm Interval 4.0 to 120.0
The Secondary Efficacy Variable Was Change in the Size of a Target Erosion in Millimeters. mean erosion week 6	4 mm Interval 0.0 to 18.0	21 mm Interval 0.0 to 120.0

Adverse Events

Pimecrolimus 1% Cream

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Vehicle Cream

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pimecrolimus 1% Cream n=10 participants at risk 0.25 grams of pimecrolimus 1% cream applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes	Vehicle Cream n=11 participants at risk 0.25 grams of vehicle cream (identical in composition and appearance to pimecrolimus 1% cream without active product) applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
Infections and infestations upper respiratory infection	40.0% 4/10 • Number of events 4	36.4% 4/11 • Number of events 4
Skin and subcutaneous tissue disorders blister on gum	0.00% 0/10	9.1% 1/11 • Number of events 1
Musculoskeletal and connective tissue disorders leg fracture	10.0% 1/10 • Number of events 1	0.00% 0/11
Skin and subcutaneous tissue disorders cold sore on lip	0.00% 0/10	9.1% 1/11 • Number of events 1
Gastrointestinal disorders flu-like illness	0.00% 0/10	9.1% 1/11 • Number of events 1

Additional Information

Dr. Christopher Hull

University of Utah

Phone: 801-581-6465

Email: christopher.hull@hsc.utah.edu

Results disclosure agreements

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