A Intra-individual Comparison to Investigate the Efficacy and the Safety of LAS41004 Formulation in Mild to Moderate Psoriasis

NCT02180464 | Completed Phase 2

• 2 other identifiers: H 553 000- 13092013-003757-22
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Proof-of concept study to competitively investigate antipsoriatic efficacy and safety of a LAS41004 formulation vs active control No formal study hypothesis, but descriptive evaluation (PoC).

Conditions

Psoriasis

Keywords

psoriasis, topical

Outcome Measures

Primary Outcomes (1)

• Total symptom score

  The primary variable is the TSS. The TSS is calculated by summarizing the individual scores for erythema, scaling and infiltration

  day 28 vs baseline

Secondary Outcomes (3)

• Total symtom score (during study performance)

  Days 4, 8, 15, and 22

• Physician's global assessment (PGA)

  Days 1, 4, 8, 15, 22 and 29

• Physician's global tolerability assessment (PGTA)

  4, 8, 15, 22 and 29

Study Arms (2)

LAS41004

EXPERIMENTAL

Topical application of approximately 2 - 6 mg/cm2 to an area of 20 - 300 cm2, each once daily

Drug: LAS41004; Drug: control

control

ACTIVE COMPARATOR

Topical application of approximately 2 - 6 mg/cm2 of IMPs 1 and 2 to an area of 20 - 300 cm2, each once daily

Drug: LAS41004; Drug: control

Interventions

LAS41004 DRUG

LAS41004; control

control DRUG

LAS41004; control

Eligibility Criteria

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

You may qualify if:

• mild to moderate stable chronic plaque-type psoriasis with at least two symmetrical lesions with a treatment area of 20 - 300 cm² and a TSS of ≥ 6;
• female volunteers of childbearing potential\* must agree to use appropriate and reliable methods of contraception
• written informed consent obtained.

You may not qualify if:

• severe forms of psoriasis or forms of psoriasis other than chronic plaque psoriasis,
• treatment with any locally acting medications which might counter or influence the trial aim within 2 weeks preceding the treatment phase of the trial and during the trial;
• treatment with any systemic medications which might counter or influence the trial aim or phototherapy/PUVA within 4 weeks preceding the treatment phase of the trial and during the trial;
• treatment with vitamin A supplements;
• treatment with any biologics within 3 months preceding the treatment phase of the trial and during the trial, or in the case of ustekinumab, within 6 months;
• treatment with any immunosuppressive medication within 6 months preceding the treatment phase of the trial and during the trial;
• known allergic reactions, irritations or hypersensitivity to the active ingredients
• contraindications according to summary of product characteristics (SmPC) of the active comparator: - pregnancy or nursing;

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (1)

Site 1

Hamburg, Germany

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Walter Wigger-Alberti, Dr med

  bioskin, Hamburg

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 2, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 10, 2015

Record last verified: 2015-06

Locations

DE (1)