Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458868
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2024-05-29
Brief Title:
An Open-label Controlled Trial Effectiveness of Balneotherapy in Palmoplantar Psoriasis and Contact Dermatitis
Sponsor:
Sifa Okulu - Independent Research Center of Dermatology and Venereology
Organization:
Sifa Okulu - Independent Research Center of Dermatology and Venereology
Study Overview
Official Title:
An Open-label Controlled Trial Effectiveness of Saltwater-UVA Tap Water-UVA and Bath PUVA in the Treatment of Palmoplantar Psoriasis and Contact Dermatitis
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients who had an indication for phototherapy were included in this study The treatment was used as a monotherapy protocol
The standard protocol for bathing PUVA involved applying 001 bath psoralen for 15 minutes while the tap water group only received a tap water bath for 15 minutes and the salt water group received 3 salted NaCl water before UVA treatment
The standard protocol for bathing PUVA involved applying 001 bath psoralen for 15 minutes while the tap water group only received a tap water bath for 15 minutes and the salt water group received 3 salted NaCl water before UVA treatment
Detailed Description:
Patients who met the criteria for phototherapy were included in this study The treatment was used as a standalone protocol with only moisturizer permitted In order to participate patients needed to have completed their last systemic treatment at least 2 months prior to the study and their last topical treatment at least 4 weeks prior
Patients were randomized using a computer program and assessed at the beginning of therapy as well as after 12 24 and 36 sessions The standard bath-PUVA protocol involved applying 001 bath psoralen for 15 minutes while the tap water group only received a tap water bath for 15 minutes and the salt water group received a 3 salt water bath before UVA exposure
All patients were educated about their condition and current treatment options Patients who participated in this study either had contraindications to other therapies or had experienced side effects previously
The initial UVA dosage was 025 Jcm2 gradually increasing to a maximum of 5 Jcm2 During each evaluation patients were assessed using various scales and tools to measure the severity of their psoriasis and their quality of life as well as photographs
Following a pilot study involving 5 patients in each group which aimed to demonstrate that there would be no difference between the treatment procedures a G power analysis determined that a total of 54 patients was needed to achieve 80 power Ethical approval was obtained before commencing the study
Patients were randomized using a computer program and assessed at the beginning of therapy as well as after 12 24 and 36 sessions The standard bath-PUVA protocol involved applying 001 bath psoralen for 15 minutes while the tap water group only received a tap water bath for 15 minutes and the salt water group received a 3 salt water bath before UVA exposure
All patients were educated about their condition and current treatment options Patients who participated in this study either had contraindications to other therapies or had experienced side effects previously
The initial UVA dosage was 025 Jcm2 gradually increasing to a maximum of 5 Jcm2 During each evaluation patients were assessed using various scales and tools to measure the severity of their psoriasis and their quality of life as well as photographs
Following a pilot study involving 5 patients in each group which aimed to demonstrate that there would be no difference between the treatment procedures a G power analysis determined that a total of 54 patients was needed to achieve 80 power Ethical approval was obtained before commencing the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None