Ignite Creation Date:
2024-05-06 @ 2:17 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02004600
Status:
WITHDRAWN
Last Update Posted:
2015-09-30
First Post:
2013-11-26
Brief Title:
Pilot Study Evaluating the Efficiency and the Tolerance of the PDT in the Treatment of Epidermal Dysplasia for Patients Affected by Hereditary DEB
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Bicentric Open and Pilot Study Evaluating the Efficiency and the Tolerance of the Photodynamic Therapy in the Treatment of Epidermal Dysplasia for Patients Affected by Hereditary Dystrophic Epidermolysis Bullosa
Status:
WITHDRAWN
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
health statement of pre-screenined patients were too bad for being enrolled in the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The hereditary dystrophic epidermolysis bullosa are genodermatosis responsible of a poor adhesion of the epidermis to the dermis pulling a large mucocutaneous fragility and recurrent spontaneous or posttraumatic bullous detachment They are caused by mutations in the COL7A1 gene encoding for the collagen VII
No curative treatment is avaible The main cause of patients death is the development of squamous cell carcinoma sometimes multiple and paticularly aggressive in repeated healing part The photodynamic therapy PDT is one of technical reference of multiple actinic keratoses lesions for adults which are also pre-epithelioma lesions The PDT is well tolerated even by the elderly and requires only a single session
The main objective of this study is to determine the efficiency of the photodynamic therapy in the treatment of epidermic dysplasies for patients affected by dystrophic epidermolysis bullosa DEB The secondary objectives are to evaluate the tolerance of this treatment in terms of pain and healing and to evaluate the contribution of confocal microscopy in the diagnosis of epidermal dysplasia for patients affected by hereditary dystrophic epidermolysis bullosa The main evaluation criterion is the cutaneous biopsy before and after M2 a PDT session of an epidermal dysplasia area The secondary criteria are the evaluation of the pain during the PDT session and the healing of the cutaneous lesion at M0 M2 and M4 lesion area and healing time and correlation histology MC Each patient with a suspicious lesion will be biopsied In case of agreement for this protocol there will be 1 PDT session followed by a consultation of control at 2 and 4 months after the end of treatment
No curative treatment is avaible The main cause of patients death is the development of squamous cell carcinoma sometimes multiple and paticularly aggressive in repeated healing part The photodynamic therapy PDT is one of technical reference of multiple actinic keratoses lesions for adults which are also pre-epithelioma lesions The PDT is well tolerated even by the elderly and requires only a single session
The main objective of this study is to determine the efficiency of the photodynamic therapy in the treatment of epidermic dysplasies for patients affected by dystrophic epidermolysis bullosa DEB The secondary objectives are to evaluate the tolerance of this treatment in terms of pain and healing and to evaluate the contribution of confocal microscopy in the diagnosis of epidermal dysplasia for patients affected by hereditary dystrophic epidermolysis bullosa The main evaluation criterion is the cutaneous biopsy before and after M2 a PDT session of an epidermal dysplasia area The secondary criteria are the evaluation of the pain during the PDT session and the healing of the cutaneous lesion at M0 M2 and M4 lesion area and healing time and correlation histology MC Each patient with a suspicious lesion will be biopsied In case of agreement for this protocol there will be 1 PDT session followed by a consultation of control at 2 and 4 months after the end of treatment
Detailed Description:
The hereditary dystrophic epidermolysis bullosa are genodermatosis responsible of a poor adhesion of the epidermis to the dermis pulling a large mucocutaneous fragility and recurrent spontaneous or posttraumatic bullous detachment They are caused by mutations in the COL7A1 gene encoding for the collagen VII
No curative treatment is avaible The main cause of patients death is the development of squamous cell carcinoma sometimes multiple and paticularly aggressive in repeated healing part The early treatment of pre-epithelioma cutaneous lesions to moderate at severe dysplasia type would undoubtedly allow to improve the prognosis of patients Because of the cutaneous fragility of patients topical treatments such as imiquimod or 5-FU are not possible The photodynamic therapy PDT is one of technical reference of multiple actinic keratoses lesions for adults which are also pre-epithelioma lesions The PDT is well tolerated even by the elderly and requires only a single session
The main objective of this study is to determine the efficiency of the photodynamic therapy in the treatment of epidermic dysplasies for patients affected by dystrophic epidermolysis bullosa DEB The secondary objectives are to evaluate the tolerance of this treatment in terms of pain and healing and to evaluate the contribution of confocal microscopy in the diagnosis of epidermal dysplasia for patients affected by hereditary dystrophic epidermolysis bullosa The main evaluation criterion is the cutaneous biopsy before and after M2 a PDT session of an epidermal dysplasia area The secondary criteria are the evaluation of the pain during the PDT session and the healing of the cutaneous lesion at M0 M2 and M4 lesion area and healing time and correlation histology MC This is a bicentric open and pilot study on 5 patients over 18 years affected by hereditary dystrophic epidermolysis bullosa with epidermal displasia Carcinomas in situ were excluded of this study Each patient with a suspicious lesion will be biopsied In case of agreement for this protocol there will be 1 PDT session followed by a consultation of control at 2 and 4 months after the end of treatment
Total study duration 18 months 12 months for inclusions 4 months for study 2 months for data analysis
No curative treatment is avaible The main cause of patients death is the development of squamous cell carcinoma sometimes multiple and paticularly aggressive in repeated healing part The early treatment of pre-epithelioma cutaneous lesions to moderate at severe dysplasia type would undoubtedly allow to improve the prognosis of patients Because of the cutaneous fragility of patients topical treatments such as imiquimod or 5-FU are not possible The photodynamic therapy PDT is one of technical reference of multiple actinic keratoses lesions for adults which are also pre-epithelioma lesions The PDT is well tolerated even by the elderly and requires only a single session
The main objective of this study is to determine the efficiency of the photodynamic therapy in the treatment of epidermic dysplasies for patients affected by dystrophic epidermolysis bullosa DEB The secondary objectives are to evaluate the tolerance of this treatment in terms of pain and healing and to evaluate the contribution of confocal microscopy in the diagnosis of epidermal dysplasia for patients affected by hereditary dystrophic epidermolysis bullosa The main evaluation criterion is the cutaneous biopsy before and after M2 a PDT session of an epidermal dysplasia area The secondary criteria are the evaluation of the pain during the PDT session and the healing of the cutaneous lesion at M0 M2 and M4 lesion area and healing time and correlation histology MC This is a bicentric open and pilot study on 5 patients over 18 years affected by hereditary dystrophic epidermolysis bullosa with epidermal displasia Carcinomas in situ were excluded of this study Each patient with a suspicious lesion will be biopsied In case of agreement for this protocol there will be 1 PDT session followed by a consultation of control at 2 and 4 months after the end of treatment
Total study duration 18 months 12 months for inclusions 4 months for study 2 months for data analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None