Efficacy, Tolerability and Safety of LAS41004 Formulations in a Psoriasis Plaque Test

NCT02111499 | Completed Phase 1

• 2 other identifiers: H553000-13082013-003754-24
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical investigation of anti-psoriatic efficacy and atrophy

Conditions

Psoriasis

Keywords

psoriasis plaque test; topical application; atrophy measure

Outcome Measures

Primary Outcomes (1)

• Area under the curve, AUC, of the width of the echo-lucent band based on sonography measurements

  The primary objective is to gain evidence suggesting efficacy of the investigational products in the treatment of plaque-type psoriasis as assessed by the AUC of the width of the echo-lucent band

  day 1 vs day 29

Secondary Outcomes (4)

• erythema and induration

  day 1 vs day 29

• local skin tolerability

  every day for 28 days

• atrophy

  day1 vs day 29

• assessment of (serious) Adverse Events

  from baseline to day 29

Study Arms (6)

formulation 1

EXPERIMENTAL

topical treatment, once daily for 4 weeks

Drug: LAS41004-IMP1; Drug: LAS41004 IMP2; Drug: LAS41004 IMP3; Drug: LAS41004 IMP4; Drug: LAS41004 IMP6; Drug: LAS41004 IMP5

formulation 2

EXPERIMENTAL

topical treatment, once daily for 4 weeks

Drug: LAS41004-IMP1; Drug: LAS41004 IMP2; Drug: LAS41004 IMP3; Drug: LAS41004 IMP4; Drug: LAS41004 IMP6; Drug: LAS41004 IMP5

formulation 3

EXPERIMENTAL

topical treatment, once daily for 4 weeks

Drug: LAS41004-IMP1; Drug: LAS41004 IMP2; Drug: LAS41004 IMP3; Drug: LAS41004 IMP4; Drug: LAS41004 IMP6; Drug: LAS41004 IMP5

formulation 4

EXPERIMENTAL

topical treatment,once daily for 4 weeks

Drug: LAS41004-IMP1; Drug: LAS41004 IMP2; Drug: LAS41004 IMP3; Drug: LAS41004 IMP4; Drug: LAS41004 IMP6; Drug: LAS41004 IMP5

formulation 5

PLACEBO COMPARATOR

topical treatment, once daily for 4 weeks

Drug: LAS41004-IMP1; Drug: LAS41004 IMP2; Drug: LAS41004 IMP3; Drug: LAS41004 IMP4; Drug: LAS41004 IMP6; Drug: LAS41004 IMP5

formulation 6

ACTIVE COMPARATOR

topical treatment, once daily for 4 weeks

Drug: LAS41004-IMP1; Drug: LAS41004 IMP2; Drug: LAS41004 IMP3; Drug: LAS41004 IMP4; Drug: LAS41004 IMP6; Drug: LAS41004 IMP5

Interventions

LAS41004-IMP1 DRUG

daily topical application

formulation 1; formulation 2; formulation 3; formulation 4; formulation 5; formulation 6

LAS41004 IMP2 DRUG

daily topical application

formulation 1; formulation 2; formulation 3; formulation 4; formulation 5; formulation 6

LAS41004 IMP3 DRUG

daily topical application

formulation 1; formulation 2; formulation 3; formulation 4; formulation 5; formulation 6

LAS41004 IMP4 DRUG

daily topical application

formulation 1; formulation 2; formulation 3; formulation 4; formulation 5; formulation 6

LAS41004 IMP6 DRUG

daily topical application

formulation 1; formulation 2; formulation 3; formulation 4; formulation 5; formulation 6

LAS41004 IMP5 DRUG

once daily, topical

formulation 1; formulation 2; formulation 3; formulation 4; formulation 5; formulation 6

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years of age
• Men and women with skin type I to IV (Fitzpatrick 1974).
• Suffering from mild to moderate plaque psoriasis of at least 6 months duration that is amenable to local therapy.
• With at least one stable psoriatic plaque in an area sufficient for product application meeting the following criteria:
• Located at the trunk and/or the extremities (plaques located on the head, palms, or soles of the feet, intertriginous or genitoanal areas are not suitable).
• Plaques with a clinical score of the parameter erythema and or induration of ≥ 2 for each sign at the screening visit. At Day 1 each parameter has to be scored ≥ 2.
• Where more than one plaque is to be used, plaques should be comparable, with at least "2" in each score for erythema and induration.
• Body surface area (BSA) involvement \< 10 %.
• Prepared to give written informed consent specific to the trial, before any assessment is performed.
• In the case of women of childbearing potential using reliable methods of contraception which result in a low failure rate i.e. less than 1% per year (e.g. contraceptive implants or injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomized partner). During the study an additional barrier method (e.g. condoms) should be used. Non-childbearing potential is defined as surgical sterilization (hysterectomy, ovariectomy or tubal ligation), postmenopausal status (continuous amenorrhea of at least 2 years).
• In the case of men with partners of childbearing potential willingness of using condoms during the study conduct and 1 month after end of treatment.

You may not qualify if:

• Patients who need systemic treatment for their psoriasis.
• Severe forms of psoriasis or forms of psoriasis other than chronic plaque psoriasis,
• Systemic treatment (see table below):
• Corticosteroids, antibiotics 4 weeks prior to trial Day 1 and during conduct of trial Retinoids Ciclosporin Methotrexate Fumaric acid esters 3 months prior to trial Day 1 and during conduct of trial Anti-inflammatory substances, NSAIDs 2 weeks prior to trial Day 1 and during conduct of trial Biologics 6 months prior to trial Day 1 and during conduct of trial
• Topical treatment of all other body regions with corticosteroids or immunosuppressants where more than 20 % of the body surface area is treated.
• Diseases:
• Significant skin infections caused by bacteria, viruses or fungi, including but not limited to tuberculosis, syphilis or varicella zoster infection Parasitic infections

Sponsors & Collaborators

• Almirall, S.A.: lead
• proDERM GmbH: collaborator

Study Sites (1)

proDERM GmbH

Schenefeld, Schleswig-Holstein, 22869, Germany

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Kirstin Deuble-Bente, Dr med

  proDERM GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: April 11, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 9, 2014

Record last verified: 2014-06

Locations

DE (1)