Back to resultsPaired Psoriasis Lesion, Comparative, Study to Evaluate MOL4239 in Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MOL4239
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring psoriasis
Eligibility Criteria
Inclusion Criteria:
- Adults, males or females, 18 to 72 years of age (both inclusive.)
- Mild to moderate plaque psoriasis with lesions that in total are no more than 9.9% BSA and with a baseline Psoriasis Severity Score (PSS) of 6 or more.
- Identification of bilaterally symmetrical or approximately equivalent target lesions of at least 2.5 x 2.5 cm (~6 cm2) on the trunk, arms or legs to mid calf with a Psoriasis Severity Score (PSS) of 6 or greater.
- Willing to avoid tanning devices or exposure of the treated skin to the sun.
- Willing to not use cosmetics, including lotions, creams, and moisturizers on the treated lesions.
- Use of Eucerin® is allowed on all non-test site areas.
- Willing to forgo systemic and other topical treatments for psoriasis during the course of the study.
- Willing to avoid bathing or swimming for two hours after study drug treatment.
- Negative urine pregnancy test at Screening and baseline for women of childbearing potential (WOCP).
- Sexually active WOCP participating in the study must agree to use a medically acceptable method of contraception while on study.
- Must have recovered from the effects of any surgery, other than minor office surgical procedures, and a minimum of 3 months must have elapsed from the day of surgery to the day of screening.
Exclusion Criteria:
- Presence of significant abnormalities of liver or renal functions.
- Presence of any clinically significant lab abnormalities at screening.
- Any significant uncontrolled medical disease.
- Use of the anti-tumor necrosis factor (TNF) biologic agents 4 months prior to randomization or use of Stelara 6 months prior to randomization.
- Use, within one month prior to baseline or during the study, of: 1) systemic immunosuppressive drugs (e.g., tacrolimus), or 2) oral meds (e.g. methotrexate, retinoids, etc.).
- Use within one month prior to baseline or during the study of: 1) Systemic corticosteroids, 2) Systemic antibiotics, 3) other systemic antipsoriatic treatment, 4) oral psoralen with ultraviolet A (PUVA) therapy, or 5) ultraviolet B (UVB) therapy.
- Use within two weeks prior to baseline or during the study of: 1) topical anti-psoriatic drugs, 2) topical corticosteroids, 3) other topical retinoids, or 4) topical immunosuppressive agents.
- Current diagnosis of unstable forms of psoriasis in the treatment area, including guttate, erythrodermic, exfoliative or pustular psoriasis.
- Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris.
- Females who are pregnant, breast feeding, or planning a pregnancy.
Sites / Locations
- International Dermatology Research, Inc.
- Minnesota Clinical Study Center
- Academic Dermatology Associates
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
10% MOL4239 ointment & placebo ointment
Arm Description
10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
Outcomes
Primary Outcome Measures
Mean Change From Baseline to Day 28 in PSS (Psoriasis Severity Score) of the Treatment Target Lesions Compared to Placebo Target Lesions
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
Trace or slight elevation of plaque above normal skin level
Moderate elevation with rounded or sloped edges to plaque
Marked elevation with hard, sharp edges to plaque
Very marked elevation with very hard, sharp edges to plaque Scaling 0 - 4
0 None
Fine scales
Coarse scales
Thick scales with a rough surface
Thick scales with a very rough surface
The scores were summed
Secondary Outcome Measures
Improvement in Lesion Appearance
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.
Physician's Treatment Preference
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.
Treatment Success
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.
Change in EIS Area
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.
Safety Assessment
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01826201
Brief Title
Paired Psoriasis Lesion, Comparative, Study to Evaluate MOL4239 in Psoriasis
Official Title
A Phase 2a, Randomized, Blinded, Paired Psoriasis Lesion, Comparative, Placebo-controlled Study to Evaluate the Safety, Preliminary Efficacy and Pharmacokinetics of Epidermal Administrations of MOL4239 in Adults With Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moleculin, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether MOL4239 is effective in adult subjects with mild to moderate plaque psoriasis by comparing two target lesions in which each subject will apply MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days.
Detailed Description
This is a phase 2a, Randomized, Multi-center, Blinded, Paired Psoriasis Lesion, Comparative Placebo-Controlled study to evaluate the safety, preliminary efficacy and pharmacokinetics of MOL4239 in 30 adult subjects with mild to moderate plaque psoriasis. Eligible subject will have a diagnosis of mild to moderate plaque psoriasis affecting 9.9% body surface area (BSA) or less, and two designated similar target lesions with a Psoriasis Severity Score of at least 6 or higher. Each subject will apply 10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
10% MOL4239 ointment & placebo ointment
Arm Type
Experimental
Arm Description
10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
Intervention Type
Drug
Intervention Name(s)
MOL4239
Intervention Description
10% MOL4239 ointment to one target lesion twice a day for 28.5 consecutive days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
Primary Outcome Measure Information:
Title
Mean Change From Baseline to Day 28 in PSS (Psoriasis Severity Score) of the Treatment Target Lesions Compared to Placebo Target Lesions
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
Trace or slight elevation of plaque above normal skin level
Moderate elevation with rounded or sloped edges to plaque
Marked elevation with hard, sharp edges to plaque
Very marked elevation with very hard, sharp edges to plaque Scaling 0 - 4
0 None
Fine scales
Coarse scales
Thick scales with a rough surface
Thick scales with a very rough surface
The scores were summed
Time Frame
Baseline and Day 28
Secondary Outcome Measure Information:
Title
Improvement in Lesion Appearance
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
Title
Physician's Treatment Preference
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
Title
Treatment Success
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
Title
Change in EIS Area
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
Title
Safety Assessment
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults, males or females, 18 to 72 years of age (both inclusive.)
Mild to moderate plaque psoriasis with lesions that in total are no more than 9.9% BSA and with a baseline Psoriasis Severity Score (PSS) of 6 or more.
Identification of bilaterally symmetrical or approximately equivalent target lesions of at least 2.5 x 2.5 cm (~6 cm2) on the trunk, arms or legs to mid calf with a Psoriasis Severity Score (PSS) of 6 or greater.
Willing to avoid tanning devices or exposure of the treated skin to the sun.
Willing to not use cosmetics, including lotions, creams, and moisturizers on the treated lesions.
Use of Eucerin® is allowed on all non-test site areas.
Willing to forgo systemic and other topical treatments for psoriasis during the course of the study.
Willing to avoid bathing or swimming for two hours after study drug treatment.
Negative urine pregnancy test at Screening and baseline for women of childbearing potential (WOCP).
Sexually active WOCP participating in the study must agree to use a medically acceptable method of contraception while on study.
Must have recovered from the effects of any surgery, other than minor office surgical procedures, and a minimum of 3 months must have elapsed from the day of surgery to the day of screening.
Exclusion Criteria:
Presence of significant abnormalities of liver or renal functions.
Presence of any clinically significant lab abnormalities at screening.
Any significant uncontrolled medical disease.
Use of the anti-tumor necrosis factor (TNF) biologic agents 4 months prior to randomization or use of Stelara 6 months prior to randomization.
Use, within one month prior to baseline or during the study, of: 1) systemic immunosuppressive drugs (e.g., tacrolimus), or 2) oral meds (e.g. methotrexate, retinoids, etc.).
Use within one month prior to baseline or during the study of: 1) Systemic corticosteroids, 2) Systemic antibiotics, 3) other systemic antipsoriatic treatment, 4) oral psoralen with ultraviolet A (PUVA) therapy, or 5) ultraviolet B (UVB) therapy.
Use within two weeks prior to baseline or during the study of: 1) topical anti-psoriatic drugs, 2) topical corticosteroids, 3) other topical retinoids, or 4) topical immunosuppressive agents.
Current diagnosis of unstable forms of psoriasis in the treatment area, including guttate, erythrodermic, exfoliative or pustular psoriasis.
Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris.
Females who are pregnant, breast feeding, or planning a pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Tschen, MD
Organizational Affiliation
Academic Dermatology Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Javier Alonso-Llamazares, MD
Organizational Affiliation
International Dermatology Research, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven Kempers, MD
Organizational Affiliation
Minnesota Clinical Study Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Dermatology Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Paired Psoriasis Lesion, Comparative, Study to Evaluate MOL4239 in Psoriasis
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