Psoriasis
Conditions
Keywords
psoriasis
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.
Interventions
DRUGMOL4239
10% MOL4239 ointment to one target lesion twice a day for 28.5 consecutive days
DRUGPlacebo
placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
Sponsors
Moleculin, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to Day 28 in PSS (Psoriasis Severity Score) of the Treatment Target Lesions Compared to Placebo Target Lesions | Baseline and Day 28 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Lesion Appearance | Baseline and Day 28 | 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 | Day 7, Day 14, Day 28 | 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 | Baseline and Day 28 | 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 | Baseline and Day 28 | 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 | Baseline and Day 28 | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 10% MOL4239 Ointment & Placebo Ointment 10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Non compliance with protocol | 4 |
Baseline characteristics
| Characteristic | 10% MOL4239 Ointment & Placebo Ointment |
|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 11.26 |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
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 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10% MOL4239 Ointment | 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 |
| Placebo Ointment | Mean Change From Baseline to Day 28 in PSS (Psoriasis Severity Score) of the Treatment Target Lesions Compared to Placebo Target Lesions | -1.5 PSS score | Standard Deviation 1.87 |
Secondary
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.
Time frame: Baseline and Day 28
Secondary
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.
Time frame: Baseline and Day 28
Secondary
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.
Time frame: Day 7, Day 14, Day 28
Population: Per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 10% MOL4239 Ointment | Physician's Treatment Preference | 0% ointment treated lesion | 5 participants |
| 10% MOL4239 Ointment | Physician's Treatment Preference | 10% ointment treated lesion | 4 participants |
| 10% MOL4239 Ointment | Physician's Treatment Preference | Neither lesion | 8 participants |
Secondary
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.
Time frame: Baseline and Day 28
Secondary
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.
Time frame: Baseline and Day 28