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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004562-33-IT

Enrollment

Registered

2013-11-18

Start date

2013-12-17

Completion date

Unknown

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SYMPTOMATIC HHD PATIENTS MedDRA version: 16.1 Level: LLT Classification code 10019029 Term: Hailey-Hailey disease System Organ Class: 100000004850

Interventions

Trade Name: SCENESSE Product Name: SCENESSE Pharmaceutical Form: Implant

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: REDUCE AND IMPROVE SYMPTOMS IN HHD PATIENTS;Secondary Objective: IMPROVE QUALITY OF LIFE REDUCE SEVERITY OF SYMPTOMS 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

Measure	Time frame
Secondary end point(s): VARIAITON IN HHDAIS AND WEIGHTING SCORE HEMATOLOGICAL PARAMETERS ADVERSE EVENTS;Timepoint(s) of evaluation of this end point: MONTHLY	—

Countries

Italy

Contacts

Public ContactGIANFRANCO BIOLCATI

ISTITUTI FISIOTERAPICI OSPITALIERI

biolcati@ifo.it

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026