Trial Outcomes & Findings for Paired Psoriasis Lesion, Comparative, Study to Evaluate MOL4239 in Psoriasis (NCT NCT01826201)
NCT ID: NCT01826201
Last Updated: 2014-12-24
Results Overview
he study drug application sites were scored for erythema, induration, and scale assessment using the PSS Scoring system. Psoriasis Severity Score (PSS) Erythema 0 - 4, 0 None, may have residual non-erythematous discoloration 1 Faint erythema 2 Moderate erythema/red color 3 Severe erythema/very red discoloration 4 Very severe erythema/extreme red coloration Induration 0 - 4 0 None 1. Trace or slight elevation of plaque above normal skin level 2. Moderate elevation with rounded or sloped edges to plaque 3. Marked elevation with hard, sharp edges to plaque 4. Very marked elevation with very hard, sharp edges to plaque Scaling 0 - 4 0 None 1. Fine scales 2. Coarse scales 3. Thick scales with a rough surface 4. Thick scales with a very rough surface The scores were summed
COMPLETED
PHASE2
21 participants
Baseline and Day 28
2014-12-24
Participant Flow
This was a multi-site study conducted at three sites in the United States of America. Date first subject enrolled: 22 April 2013 and date last subject completed: 13 August 2013.
Participant milestones
| Measure |
0% and 10% MOL4239 Ointment
10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
0% and 10% MOL4239 Ointment
10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
|
|---|---|
|
Overall Study
Non compliance with protocol
|
4
|
Baseline Characteristics
Paired Psoriasis Lesion, Comparative, Study to Evaluate MOL4239 in Psoriasis
Baseline characteristics by cohort
| Measure |
10% MOL4239 Ointment & Placebo Ointment
n=21 Participants
10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
|
|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 11.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 28he study drug application sites were scored for erythema, induration, and scale assessment using the PSS Scoring system. Psoriasis Severity Score (PSS) Erythema 0 - 4, 0 None, may have residual non-erythematous discoloration 1 Faint erythema 2 Moderate erythema/red color 3 Severe erythema/very red discoloration 4 Very severe erythema/extreme red coloration Induration 0 - 4 0 None 1. Trace or slight elevation of plaque above normal skin level 2. Moderate elevation with rounded or sloped edges to plaque 3. Marked elevation with hard, sharp edges to plaque 4. Very marked elevation with very hard, sharp edges to plaque Scaling 0 - 4 0 None 1. Fine scales 2. Coarse scales 3. Thick scales with a rough surface 4. Thick scales with a very rough surface The scores were summed
Outcome measures
| Measure |
10% MOL4239 Ointment
n=17 Target Lesions
10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
|
Placebo Ointment
n=17 Target Lesions
10% MOL4239 to one target lesion and placebo to contralateral target lesion
|
|---|---|---|
|
Mean Change From Baseline to Day 28 in PSS (Psoriasis Severity Score) of the Treatment Target Lesions Compared to Placebo Target Lesions
|
-1.9 PSS score
Standard Deviation 1.45
|
-1.5 PSS score
Standard Deviation 1.87
|
SECONDARY outcome
Timeframe: Baseline and Day 28Photography of the MOL4239 and placebo treated lesions will be performed at baseline, Day 7, Day 14 and Day 28 to assess for the improvement in lesion appearance after drug treatment. The assessment will be completed by a blinded panel of dermatologists experienced in the assessment of psoriasis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 7, Day 14, Day 28Population: Per protocol
The physician's treatment preference utilizing visual assessment and selection of the most improved plaque. The determination will be either 1)right lesion is preferred compared to left, 2)left lesion is preferred compared to right, 3) no difference between the right and left lesion.
Outcome measures
| Measure |
10% MOL4239 Ointment
n=34 lesions
10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
|
Placebo Ointment
10% MOL4239 to one target lesion and placebo to contralateral target lesion
|
|---|---|---|
|
Physician's Treatment Preference
0% ointment treated lesion
|
5 participants
|
—
|
|
Physician's Treatment Preference
10% ointment treated lesion
|
4 participants
|
—
|
|
Physician's Treatment Preference
Neither lesion
|
8 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 28Percent of patients achieving treatment success in the treatment group compared to the placebo group on day 28. Treatment success is defined as patient achieving a psoriasis severity score (PSS) of 3 or less, or an improvement of 5 points or more on the PSS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Day 28Change in Erythema, Induration and Scale (EIS) area. Total score will be the EIS x Area, and will be calculated at baseline, Day 7, Day 14 and Day 28. The EIS will represent the sum of individual scores of Erythema, Induration and Scale using the same scale utilized in the PSS. The area of active erythema, induration and scale will be measured and the total scores will be calculated from the EIS scores multiplied by the area in cm2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Day 28Safety will be assessed based on reported adverse events, physical examination, vital signs, electrocardiograms, hematology, serum chemistry and urinalysis. Adverse events will be reported throughout the trial. Vital signs will be performed at screening, baseline, prior to the morning dose on Days 0, 1, 7, 14, 28, and at the follow up visit on Day 42. Physical examinations will be performed at Screening, baseline and Day 28. Hematology, serum chemistry and urinalysis will be performed at screening, baseline, Days 1, 7, 14, 28, and at the follow up visit on Day 42. ECGs will be performed at Screening, baseline and Day 28.
Outcome measures
Outcome data not reported
Adverse Events
0% and 10% MOL4239 Ointment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0% and 10% MOL4239 Ointment
n=21 participants at risk
10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
|
|---|---|
|
Renal and urinary disorders
Haematuria
|
9.5%
2/21
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor approves content of communication.
- Publication restrictions are in place
Restriction type: OTHER