"ENSAYO CLÍNICO MULTICÉNTRICO, FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO INTRAINDIVIDUALMENTE CON PLACEBO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE P144 EN EL TRATAMIENTO TÓPICO DE LA FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICA" "PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS"

• Register: EUCTR
• Last refreshed on: 29 May 2012
• Main ID: EUCTR2007-002015-38-ES
• Date of registration: 02/07/2007
• Prospective Registration: Yes
• Primary sponsor: ISDIN
• Public title: "ENSAYO CLÍNICO MULTICÉNTRICO, FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO INTRAINDIVIDUALMENTE CON PLACEBO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE P144 EN EL TRATAMIENTO TÓPICO DE LA FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICA" "PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS"
• Scientific title: "ENSAYO CLÍNICO MULTICÉNTRICO, FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO INTRAINDIVIDUALMENTE CON PLACEBO, PARA EVALUAR LA EFICACIA Y SEGURIDAD DE P144 EN EL TRATAMIENTO TÓPICO DE LA FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICA" "PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, INTRAINDIVIDUALLY PLACEBO CONTROLLED CLINICAL TRIAL, TO EVALUATE EFFICACY AND SAFETY OF P144 TOPICAL ADMINISTRATION FOR SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS"
• Date of first enrolment: 23/08/2007
• Target sample size: 98
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002015-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: INTRAINDIVIDUALLY PLACEBO CONTROLLED If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany, Hungary, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
· Patients male and female >18 < 65 years at time of consent.
· History of Systemic sclerosis (including diffuse scleroderma and limited scleroderma) for less than three years of evolution from the onset of cutaneous manifestations.
· Symmetric lesions in forearms. The extension of the selected symmetric lesions must be at least 15 cm2.
· Stable therapy for at least one month, except in the case of patients under treatment with putative disease modifying agents (immunosupressants like cyclophosphamide, methotrexate or azathioprine) that will need at least three months of stable therapy, without the expectation of treatment modifications during the trial period.
· Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.
· For female subjects with childbearing potential: use of a known highly effective method of birth control, defined as those which results in a low failure rate: i.e. less 1% per year, (contraceptive pills, intrauterine contraceptive device, implants, vasectomized partner or sexual abstinence), for at least three consecutive months prior to the study, during the study and one month after the end of the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
· Patients diagnosed of:
o Systemic sclerosis sine scleroderma.
o Localized scleroderma.
o Eosinophilic fascitis, eosinophilia myalgia syndrome.
· Any other definable connective tissue disease, such as rheumatoid arthritis, systemic lupus erythematosus, polymyositis, or dermatomyositis.
· Clinically significant overlap condition.
· Significant existing internal organ damage (Kidney, Cardiovascular disease, Pulmonary disease, Gastrointestinal disease) as defined in “Guidelines for clinical trial in systemic sclerosis (scleroderma) “
· History of skin cancer.
· Other skin diseases affecting the treatment area.
· Patients with substantial history of environmental exposure to tainted rapeseed oil, vinyl chloride, L- tryptophan, bleomycin, trichoroethylene, or silica.
· PUVA therapy within 1 month of study drug initiation.
· Concurrent interventional therapy that might independently influence outcome of trial, such as D-penicillamine, cyclosporine, interferon-g or photopheresis.
· Topical corticosteroids treatment affecting the selected area.
· Cosmetics over the treatment area.
· Pregnant or breast-feeding women.
· Reasonable expectation that the subject will not be able to satisfactorily complete the study:
o History of or current psychiatric illness that would interfere with the subject’s ability to comply with protocol requirements or give informed consent.
o History of alcohol or drug abuse that would interfere with the subject’s ability to comply with protocol requirements.
o Receipt of any investigational drug within three months of screening visit.
o Documented noncompliance.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

"FIBROSIS CUTÁNEA DE PACIENTES CON ESCLEROSIS SISTÉMICA" "SKIN FIBROSIS IN PATIENTS WITH SYSTEMIC SCLEROSIS"
MedDRA version: 9.1 Level: LLT Classification code 10039710 Term: Scleroderma

Intervention(s)

Product Name: P144
Product Code: P144
Pharmaceutical Form: Cream
CAS Number: 272105-42-7
Current Sponsor code: P144
Other descriptive name: DIGNA P144 CREAM
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 0.03%-
Pharmaceutical form of the placebo: Cream
Route of administration of the placebo: Topical use (Noncurrent)

Primary Outcome(s)

Main Objective: The primary objective is to asses the efficacy of P144 topically administered in skin lesions of systemic sclerosis patients throw the measure of soluble collagen content and durometry over three months.

Secondary Objective: The secondary objectives are to evaluate the efficacy (measured by histology with immunohistochemical and molecular markers analyses), as well as the safety, quality of life and pharmacokinetics of P144 topically administered one a day for up to three months.

Primary end point(s): Soluble collagen content and skin hardness.

Secondary ID(s)

ISD002-P144-07