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PsoriasisPhase 2NCT01826201

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

A Phase 2 study testing MOL4239 in people with Psoriasis, run by Moleculin, LLC at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 72 years
Conditions the study is for
Psoriasis
What is being tested?
MOL4239
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
3 sitesUnited States
Study dates
Mar 2013to Aug 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 72 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Academic Dermatology Associates

    Albuquerque, New Mexico, 87106

  • Minnesota Clinical Study Center

    Fridley, Minnesota, 55432

  • International Dermatology Research, Inc.

    Miami, Florida, 33144

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Psoriasis
Being tested
MOL4239, Placebo
Keywords
psoriasis
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MOL4239Drug

    10% MOL4239 ointment to one target lesion twice a day for 28.5 consecutive days

  • PlaceboDrug

    placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days

Study groups in NCT01826201
Study groupRoleWhat they receive
10% MOL4239 ointment & placebo ointmentExperimental10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
Receives: Drug: MOL4239; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline and Day 28

Secondary outcomes (5)

  1. 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.

    Measured: Baseline and Day 28

  2. 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.

    Measured: Day 7, Day 14, Day 28

  3. 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.

    Measured: Baseline and Day 28

  4. 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.

    Measured: Baseline and Day 28

  5. 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.

    Measured: Baseline and Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01826201
Sponsor's protocol ID
M-02
Status last verified
Dec 2014
First submitted
21 Mar 2013
Last updated
24 Dec 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MOL4239 in people with Psoriasis, run by Moleculin, LLC at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline to Day 28 in PSS (Psoriasis Severity Score) of the Treatment Target Lesions Compared to Placebo Target Lesions (time frame: Baseline and Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01826201.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2014.

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