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Topical Solution for the Treatment of Atopic Dermatitis

NCT02865356 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-04-17

No results posted yet for this study

Summary

The study is designed as a proof of concept, multi-center, randomized, double-blind and vehicle-controlled study with intra-individual comparison of treatments.

Three age cohorts of patients will be included in the study according to the following age ranges:

1. ≥18 years old (minimum 6, maximum 18 patients)
2. \>12 - 17 years old (minimum 6, maximum 18 patients)
3. \>2 - 12 years old (minimum 6, maximum 18 patients)

The main objectives of study are:

To assess the efficacy of SP14019-F-01 topical solution (5% cyclosporine A \[CsA\]) compared to placebo topical solution for the treatment of patients with mild to moderate atopic dermatitis (AD).

To evaluate the safety and tolerability of SP14019-F-01 (5% CsA) topical solution in patients with mild to moderate AD.

Conditions

Interventions

DRUG

Cyclosporine 5% solution

topical solution

DRUG

Placebo

topical vehicle solution

Sponsors & Collaborators

  • Germans Trias i Pujol Hospital

    collaborator OTHER

  • Hospital del Mar

    collaborator OTHER

  • Hospital Sant Joan de Deu

    collaborator OTHER

  • Hospital Universitario Virgen Macarena

    collaborator OTHER

  • Hospital Universitario La Fe

    collaborator OTHER

  • Hospital General Universitario de Alicante

    collaborator OTHER

  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    collaborator OTHER

  • Hospital Universitario Virgen de la Victoria

    collaborator OTHER

  • Hospital Infantil Universitario Niño Jesús, Madrid, Spain

    collaborator OTHER

  • Spherium Biomed

    lead INDUSTRY

Principal Investigators

  • Carlos Ferrándiz, MD, PhD · Germans Trias i Pujol Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-04-12
Completion
2017-04-12

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02865356 on ClinicalTrials.gov