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

NCT01826201 | Completed Phase 2 Results

• 1 other identifier: M-02
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

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.

Conditions

Psoriasis

Keywords

psoriasis

Outcome Measures

Primary Outcomes (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

  Baseline and Day 28

Secondary Outcomes (5)

• Improvement in Lesion Appearance

  Baseline and Day 28

• Physician's Treatment Preference

  Day 7, Day 14, Day 28

• Treatment Success

  Baseline and Day 28

• Change in EIS Area

  Baseline and Day 28

• Safety Assessment

  Baseline and Day 28

Study Arms (1)

10% MOL4239 ointment & placebo ointment

EXPERIMENTAL

10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days

Drug: MOL4239; Drug: Placebo

Interventions

MOL4239 DRUG

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

10% MOL4239 ointment & placebo ointment

Placebo DRUG

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

10% MOL4239 ointment & placebo ointment

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Moleculin, LLC: lead

Study Sites (3)

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Moleculin, LLC

Carena@moleculin.com

713-953-7676

Study Officials

• Eduardo Tschen, MD

  Academic Dermatology Associates

  PRINCIPAL INVESTIGATOR

• Javier Alonso-Llamazares, MD

  International Dermatology Research, Inc.

  PRINCIPAL INVESTIGATOR

• Steven Kempers, MD

  Minnesota Clinical Study Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: April 8, 2013
• Study Start: March 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 24, 2014
• Results First Posted: December 24, 2014

Record last verified: 2014-12

Locations

US (3)