PHASE II STUDY TO EVALUATE SAFETY AND EFFICACY OF A BIO-RIASSORBABLE SUBCUTANEOUS IMPLANT OF AFAMELANOTIDE IN HAILEY-HAILEY DISEASE (HHD) PATIENTS

Phase 1

• Conditions: SYMPTOMATIC HHD PATIENTS; MedDRA version: 16.1Level: LLTClassification code 10019029Term: Hailey-Hailey diseaseSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2013-004562-33-IT
• Lead Sponsor: ISTITUTI FISIOTERAPICI OSPITALIERI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-18
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

MALE AND FEMALE WITH A CLINICAL/HISTOLOGICAL/GENETIC DIAGNOSIS OF HHD
AN AREA INDEX SCORE >2
AGE FROM 18 TO 80 YEARS
SIGNED CONSENT FORM
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 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

ALLERGY TO AFAMELANOTIDE
HISTORY OF MELANOMA, BOWEN DISEASE, SQUAMOUS CELL CARCINOMA
PREGNANCY
NOT USE OF CONTRACTCEPTIVE

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: REDUCE AND IMPROVE SYMPTOMS IN HHD PATIENTS;Secondary Objective: IMPROVE QUALITY OF LIFE<br>REDUCE SEVERITY OF SYMPTOMS<br>EVALUATE SAFETY OF AFAMELANOTIDE;Primary end point(s): DIFFERENCE BETWEEN T0 AND 12 MONTHS USING HHDAIS;Timepoint(s) of evaluation of this end point: 12 MONTHS

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): VARIAITON IN HHDAIS AND WEIGHTING SCORE<br>HEMATOLOGICAL PARAMETERS<br>ADVERSE EVENTS;Timepoint(s) of evaluation of this end point: MONTHLY