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Paired Psoriasis Lesion, Comparative, Study to Evaluate MOL4239 in Psoriasis

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ClinicalTrials.gov Identifier: NCT01826201
Recruitment Status : Completed
First Posted : April 8, 2013
Results First Posted : December 24, 2014
Last Update Posted : December 24, 2014
Sponsor:
Information provided by (Responsible Party):
Moleculin, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: MOL4239
Drug: Placebo
Enrollment 21
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title 0% and 10% MOL4239 Ointment
Hide Arm/Group Description 10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
Period Title: Overall Study
Started 21 [1]
Completed 17
Not Completed 4
Reason Not Completed
Non compliance with protocol             4
[1]
Subjects in each arm are same
Arm/Group Title 10% MOL4239 Ointment & Placebo Ointment
Hide Arm/Group Description 10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants
53  (11.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
9
  42.9%
Male
12
  57.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants
21
1.Primary Outcome
Title Mean Change From Baseline to Day 28 in PSS (Psoriasis Severity Score) of the Treatment Target Lesions Compared to Placebo Target Lesions
Hide Description

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

Time Frame Baseline and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 10% MOL4239 Ointment Placebo Ointment
Hide Arm/Group Description:
10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
10% MOL4239 to one target lesion and placebo to contralateral target lesion
Overall Number of Participants Analyzed 17 17
Overall Number of Units Analyzed
Type of Units Analyzed: Target Lesions
17 17
Mean (Standard Deviation)
Unit of Measure: PSS score
-1.9  (1.45) -1.5  (1.87)
2.Secondary Outcome
Title Improvement in Lesion Appearance
Hide Description Photography 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.
Time Frame Baseline and Day 28
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Physician's Treatment Preference
Hide Description 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.
Time Frame Day 7, Day 14, Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title 0% and 10% MOL4239 Ointment
Hide Arm/Group Description:
10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
Overall Number of Participants Analyzed 17
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
34
Measure Type: Number
Unit of Measure: participants
0% ointment treated lesion 5
10% ointment treated lesion 4
Neither lesion 8
4.Secondary Outcome
Title Treatment Success
Hide Description Percent 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.
Time Frame Baseline and Day 28
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change in EIS Area
Hide Description Change 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.
Time Frame Baseline and Day 28
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Safety Assessment
Hide Description Safety 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.
Time Frame Baseline and Day 28
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 0% and 10% MOL4239 Ointment
Hide Arm/Group Description 10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
All-Cause Mortality
0% and 10% MOL4239 Ointment
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
0% and 10% MOL4239 Ointment
Affected / at Risk (%)
Total   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
0% and 10% MOL4239 Ointment
Affected / at Risk (%)
Total   2/21 (9.52%) 
Renal and urinary disorders   
Haematuria   2/21 (9.52%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor approves content of communication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Moleculin, LLC
Phone: 713-953-7676 ext 232
EMail: Carena@moleculin.com
Layout table for additonal information
Responsible Party: Moleculin, LLC
ClinicalTrials.gov Identifier: NCT01826201     History of Changes
Other Study ID Numbers: M-02
First Submitted: March 21, 2013
First Posted: April 8, 2013
Results First Submitted: November 11, 2014
Results First Posted: December 24, 2014
Last Update Posted: December 24, 2014