Trial Outcomes & Findings for A Multiple-Dose Study to Evaluate Skin Irritation and Sensitization of Teriparatide Administered Transdermally in Healthy Postmenopausal Women (NCT NCT01250145)
NCT ID: NCT01250145
Last Updated: 2012-10-23
Results Overview
Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation. Score 0 = No Erythema/Edema; Score 1 = Very slight Erythema/Edema (barely perceptible); Score 2 = Well defined Erythema/Edema (edges of area well defined by definite raising); Score 3 = Moderate to Severe Erythema/Edema (raised approximately 1 millimeter \[mm\]).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
251 participants
Primary outcome timeframe
Day 1 through Day 22
Results posted on
2012-10-23
Participant Flow
Participant milestones
| Measure |
LY333334 + Placebo: Part A
Part A:
Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days
|
LY333334 + Placebo: Part B
Part B:
Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks
Rest phase: 2 weeks with no patch application
Challenge phase: 80 microgram active patch given once for at least 6 hours
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
210
|
|
Overall Study
COMPLETED
|
39
|
205
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
LY333334 + Placebo: Part A
Part A:
Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days
|
LY333334 + Placebo: Part B
Part B:
Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks
Rest phase: 2 weeks with no patch application
Challenge phase: 80 microgram active patch given once for at least 6 hours
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
Baseline Characteristics
A Multiple-Dose Study to Evaluate Skin Irritation and Sensitization of Teriparatide Administered Transdermally in Healthy Postmenopausal Women
Baseline characteristics by cohort
| Measure |
LY333334 + Placebo: Part A
n=41 Participants
Part A:
Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days
|
LY333334 + Placebo: Part B
n=210 Participants
Part B:
Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks
Rest phase: 2 weeks with no patch application
Challenge phase: 80 microgram active patch given once for at least 6 hours
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
60.2 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
59.9 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
210 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 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
United States
|
41 participants
n=5 Participants
|
33 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=5 Participants
|
103 participants
n=7 Participants
|
103 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=5 Participants
|
74 participants
n=7 Participants
|
74 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 22Population: All participants who entered the study and received patches are included in the analysis.
Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation. Score 0 = No Erythema/Edema; Score 1 = Very slight Erythema/Edema (barely perceptible); Score 2 = Well defined Erythema/Edema (edges of area well defined by definite raising); Score 3 = Moderate to Severe Erythema/Edema (raised approximately 1 millimeter \[mm\]).
Outcome measures
| Measure |
Part A: Active Patch - Prior to Patch Application
n=888 Patches
Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores prior to patch application.
|
Part A: Active Patch - 1 Hour Post Patch Removal
n=890 Patches
Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 1 hour after patch removal.
|
Part A: Active Patch - 24 Hours Post Patch Application
n=887 Patches
Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 24 hours after patch application.
|
Part A: Placebo Patch - Prior to Patch Application
n=888 Patches
Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores prior to patch application.
|
Part A: Placebo Patch - 1 Hour Post Patch Removal
n=890 Patches
Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 1 hour after patch removal.
|
Part A: Placebo Patch - 24 Hours Post Patch Application
n=887 Patches
Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 24 hours after patch application.
|
|---|---|---|---|---|---|---|
|
Part A - Cumulative Skin Irritation by Draize Score
Erythema: Score 1
|
523 patches with Draize scores
|
674 patches with Draize scores
|
633 patches with Draize scores
|
452 patches with Draize scores
|
713 patches with Draize scores
|
601 patches with Draize scores
|
|
Part A - Cumulative Skin Irritation by Draize Score
Erythema: Score 0
|
299 patches with Draize scores
|
40 patches with Draize scores
|
146 patches with Draize scores
|
390 patches with Draize scores
|
69 patches with Draize scores
|
205 patches with Draize scores
|
|
Part A - Cumulative Skin Irritation by Draize Score
Erythema: Score 2
|
65 patches with Draize scores
|
176 patches with Draize scores
|
106 patches with Draize scores
|
45 patches with Draize scores
|
108 patches with Draize scores
|
79 patches with Draize scores
|
|
Part A - Cumulative Skin Irritation by Draize Score
Erythema: Score 3
|
1 patches with Draize scores
|
0 patches with Draize scores
|
2 patches with Draize scores
|
1 patches with Draize scores
|
0 patches with Draize scores
|
2 patches with Draize scores
|
|
Part A - Cumulative Skin Irritation by Draize Score
Edema: Score 0
|
604 patches with Draize scores
|
113 patches with Draize scores
|
370 patches with Draize scores
|
716 patches with Draize scores
|
298 patches with Draize scores
|
539 patches with Draize scores
|
|
Part A - Cumulative Skin Irritation by Draize Score
Edema: Score 1
|
270 patches with Draize scores
|
600 patches with Draize scores
|
454 patches with Draize scores
|
166 patches with Draize scores
|
511 patches with Draize scores
|
322 patches with Draize scores
|
|
Part A - Cumulative Skin Irritation by Draize Score
Edema: Score 2
|
13 patches with Draize scores
|
175 patches with Draize scores
|
62 patches with Draize scores
|
5 patches with Draize scores
|
80 patches with Draize scores
|
26 patches with Draize scores
|
|
Part A - Cumulative Skin Irritation by Draize Score
Edema: Score 3
|
1 patches with Draize scores
|
1 patches with Draize scores
|
1 patches with Draize scores
|
1 patches with Draize scores
|
0 patches with Draize scores
|
0 patches with Draize scores
|
PRIMARY outcome
Timeframe: Days 1 - 19 and 34 - 37Population: All participants who entered the study and received patches are included in the analysis.
Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation and sensitization. Score 0 = No Erythema/Edema; Score 1 = Very slight Erythema/Edema (barely perceptible); Score 2 = Well defined Erythema/Edema (edges of area well defined by definite raising); Score 3 = Moderate to Severe Erythema/Edema (raised approximately 1 mm); Score 4 = Severe Edema (raised more than 1 mm and extending beyond area of exposure).
Outcome measures
| Measure |
Part A: Active Patch - Prior to Patch Application
n=2479 Patches
Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores prior to patch application.
|
Part A: Active Patch - 1 Hour Post Patch Removal
n=2479 Patches
Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 1 hour after patch removal.
|
Part A: Active Patch - 24 Hours Post Patch Application
n=210 Participants
Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 24 hours after patch application.
|
Part A: Placebo Patch - Prior to Patch Application
n=210 Participants
Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores prior to patch application.
|
Part A: Placebo Patch - 1 Hour Post Patch Removal
n=210 Participants
Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 1 hour after patch removal.
|
Part A: Placebo Patch - 24 Hours Post Patch Application
n=210 Participants
Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 24 hours after patch application.
|
|---|---|---|---|---|---|---|
|
Part B - Skin Irritation and Sensitization by Draize Score
Erythema: Score 0
|
1399 patches with Draize scores
|
122 patches with Draize scores
|
436 patches with Draize scores
|
1525 patches with Draize scores
|
271 patches with Draize scores
|
784 patches with Draize scores
|
|
Part B - Skin Irritation and Sensitization by Draize Score
Erythema: Score 1
|
1050 patches with Draize scores
|
1503 patches with Draize scores
|
1899 patches with Draize scores
|
924 patches with Draize scores
|
1698 patches with Draize scores
|
1578 patches with Draize scores
|
|
Part B - Skin Irritation and Sensitization by Draize Score
Erythema: Score 2
|
30 patches with Draize scores
|
840 patches with Draize scores
|
138 patches with Draize scores
|
25 patches with Draize scores
|
495 patches with Draize scores
|
107 patches with Draize scores
|
|
Part B - Skin Irritation and Sensitization by Draize Score
Erythema: Score 3
|
0 patches with Draize scores
|
14 patches with Draize scores
|
1 patches with Draize scores
|
0 patches with Draize scores
|
10 patches with Draize scores
|
0 patches with Draize scores
|
|
Part B - Skin Irritation and Sensitization by Draize Score
Edema: Score 0
|
2280 patches with Draize scores
|
930 patches with Draize scores
|
1759 patches with Draize scores
|
2330 patches with Draize scores
|
1572 patches with Draize scores
|
2014 patches with Draize scores
|
|
Part B - Skin Irritation and Sensitization by Draize Score
Edema: Score 1
|
197 patches with Draize scores
|
1141 patches with Draize scores
|
661 patches with Draize scores
|
143 patches with Draize scores
|
766 patches with Draize scores
|
435 patches with Draize scores
|
|
Part B - Skin Irritation and Sensitization by Draize Score
Edema: Score 2
|
2 patches with Draize scores
|
399 patches with Draize scores
|
53 patches with Draize scores
|
1 patches with Draize scores
|
136 patches with Draize scores
|
19 patches with Draize scores
|
|
Part B - Skin Irritation and Sensitization by Draize Score
Edema: Score 3
|
0 patches with Draize scores
|
5 patches with Draize scores
|
1 patches with Draize scores
|
0 patches with Draize scores
|
0 patches with Draize scores
|
1 patches with Draize scores
|
|
Part B - Skin Irritation and Sensitization by Draize Score
Edema: Score 4
|
0 patches with Draize scores
|
4 patches with Draize scores
|
0 patches with Draize scores
|
0 patches with Draize scores
|
0 patches with Draize scores
|
0 patches with Draize scores
|
SECONDARY outcome
Timeframe: Day 1 through Day 22Population: All randomized participants who received a patch.
Number of patches with adhesion score. Score 0 = ≥90% adhered (essentially no lift off the skin); Score 1= ≥75% to \<90% adhered (some edges only lifting off the skin); Score 2 = ≥50% to \<75% adhered (less than half of the patch lifting off the skin); Score 3 = \>0% to \<50% adhered but not detached (more than half of the patch lifting off the skin without falling off); Score 4 = 0% adhered - patch detached (patch completely off the skin).
Outcome measures
| Measure |
Part A: Active Patch - Prior to Patch Application
n=889 Patches
Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores prior to patch application.
|
Part A: Active Patch - 1 Hour Post Patch Removal
n=889 Patches
Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 1 hour after patch removal.
|
Part A: Active Patch - 24 Hours Post Patch Application
Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 24 hours after patch application.
|
Part A: Placebo Patch - Prior to Patch Application
Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores prior to patch application.
|
Part A: Placebo Patch - 1 Hour Post Patch Removal
Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 1 hour after patch removal.
|
Part A: Placebo Patch - 24 Hours Post Patch Application
Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 24 hours after patch application.
|
|---|---|---|---|---|---|---|
|
Part A - Patch Adhesion Score
Score 0
|
879 patches with adhesive score
|
882 patches with adhesive score
|
—
|
—
|
—
|
—
|
|
Part A - Patch Adhesion Score
Score 1
|
8 patches with adhesive score
|
7 patches with adhesive score
|
—
|
—
|
—
|
—
|
|
Part A - Patch Adhesion Score
Score 2
|
1 patches with adhesive score
|
0 patches with adhesive score
|
—
|
—
|
—
|
—
|
|
Part A - Patch Adhesion Score
Score 3
|
0 patches with adhesive score
|
0 patches with adhesive score
|
—
|
—
|
—
|
—
|
|
Part A - Patch Adhesion Score
Score 4
|
1 patches with adhesive score
|
0 patches with adhesive score
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 - 19 and 34 - 37Population: All randomized participants who received a patch.
Number of patches with adhesion score. Score 0 = ≥90% adhered (essentially no lift off the skin); Score 1= ≥75% to \<90% adhered (some edges only lifting off the skin); Score 2 = ≥50% to \<75% adhered (less than half of the patch lifting off the skin); Score 3 = \>0% to \<50% adhered but not detached (more than half of the patch lifting off the skin without falling off); Score 4 = 0% adhered - patch detached (patch completely off the skin).
Outcome measures
| Measure |
Part A: Active Patch - Prior to Patch Application
n=2683 Patches
Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores prior to patch application.
|
Part A: Active Patch - 1 Hour Post Patch Removal
n=2678 Patches
Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 1 hour after patch removal.
|
Part A: Active Patch - 24 Hours Post Patch Application
Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 24 hours after patch application.
|
Part A: Placebo Patch - Prior to Patch Application
Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores prior to patch application.
|
Part A: Placebo Patch - 1 Hour Post Patch Removal
Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 1 hour after patch removal.
|
Part A: Placebo Patch - 24 Hours Post Patch Application
Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 24 hours after patch application.
|
|---|---|---|---|---|---|---|
|
Part B - Patch Adhesion Score
Score 4
|
13 patches with adhesive score
|
5 patches with adhesive score
|
—
|
—
|
—
|
—
|
|
Part B - Patch Adhesion Score
Score 0
|
2608 patches with adhesive score
|
2608 patches with adhesive score
|
—
|
—
|
—
|
—
|
|
Part B - Patch Adhesion Score
Score 1
|
40 patches with adhesive score
|
31 patches with adhesive score
|
—
|
—
|
—
|
—
|
|
Part B - Patch Adhesion Score
Score 2
|
13 patches with adhesive score
|
17 patches with adhesive score
|
—
|
—
|
—
|
—
|
|
Part B - Patch Adhesion Score
Score 3
|
9 patches with adhesive score
|
17 patches with adhesive score
|
—
|
—
|
—
|
—
|
Adverse Events
LY333334 + Placebo: Part A
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
LY333334 + Placebo: Part B
Serious events: 2 serious events
Other events: 157 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY333334 + Placebo: Part A
n=41 participants at risk
Part A:
Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days
|
LY333334 + Placebo: Part B
n=210 participants at risk
Part B:
Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks
Rest phase: 2 weeks with no patch application
Challenge phase: 80 microgram active patch given once for at least 6 hours
|
|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/41
|
0.48%
1/210 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/41
|
0.48%
1/210 • Number of events 1
|
Other adverse events
| Measure |
LY333334 + Placebo: Part A
n=41 participants at risk
Part A:
Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days
|
LY333334 + Placebo: Part B
n=210 participants at risk
Part B:
Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks
Rest phase: 2 weeks with no patch application
Challenge phase: 80 microgram active patch given once for at least 6 hours
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/41
|
8.1%
17/210 • Number of events 18
|
|
General disorders
Application site erythema
|
0.00%
0/41
|
14.8%
31/210 • Number of events 79
|
|
General disorders
Application site pain
|
9.8%
4/41 • Number of events 6
|
5.7%
12/210 • Number of events 19
|
|
General disorders
Application site pruritus
|
26.8%
11/41 • Number of events 25
|
15.7%
33/210 • Number of events 88
|
|
General disorders
Fatigue
|
0.00%
0/41
|
6.2%
13/210 • Number of events 13
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/41
|
5.2%
11/210 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/41
|
5.7%
12/210 • Number of events 14
|
|
Nervous system disorders
Headache
|
12.2%
5/41 • Number of events 9
|
25.2%
53/210 • Number of events 74
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.3%
3/41 • Number of events 3
|
6.2%
13/210 • Number of events 17
|
|
Gastrointestinal disorders
Constipation
|
19.5%
8/41 • Number of events 9
|
0.00%
0/210
|
|
General disorders
Application site erosion
|
19.5%
8/41 • Number of events 11
|
0.00%
0/210
|
|
General disorders
Application site vesicles
|
7.3%
3/41 • Number of events 4
|
0.00%
0/210
|
|
General disorders
Nasal congestion
|
7.3%
3/41 • Number of events 3
|
0.00%
0/210
|
|
Vascular disorders
Hot flush
|
7.3%
3/41 • Number of events 3
|
0.00%
0/210
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60