Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425789
Status:
UNKNOWN
Last Update Posted:
2011-04-05
First Post:
2007-01-22
Brief Title:
Hyperbaric Therapy and Deep Chemical Peeling
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
Hyperbaric Therapy and Healing From Deep Chemical Peel
Status:
UNKNOWN
Status Verified Date:
2005-12
Last Known Status:
RECRUITING
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:
To evaluate whether treatment with Hyperbaric oxygen can accelerate skin recovery after deep peeling and decrease frequency and severity of local side effects and complications
20 post peel patients will recieve 5 daily hyperbaric treatments starting from day 7 to peelPatients followup will include self- filling questionnaire and photographs
20 post peel patients will recieve 5 daily hyperbaric treatments starting from day 7 to peelPatients followup will include self- filling questionnaire and photographs
Detailed Description:
The study will include 40 post-deep peel women exoderm older than 18 years old treated by the same dermatologist
The treatment group will recieve 5 consecutive daily hyperbaric treatments 1 hours long each at 2 ATF starting from day 7 to peel Prior to treatment each patient will be signed on informed consent and will have complete physical examination
The control group will be matched by the following parameters age skin color and type and indication for peeling and will be picked up by the dermatologist
Patients will be excluded if they have known middle ear disease chronic lung disease or claustrophobia
Follow -up
The same dermatologist will follow-up on regular dates the follow-up examination will start at day 1 to maskocclusive dressing removal equivalent to day 7 post-peel and at days 7 28 and after 3 months All follow-up examinations will take place at noon 04-08 pm regularly
Efficacy parameters
All patients will be asked to fill up a daily questionnaire on the first week after peel and score the severity of pain pruritus and tightness of facial skin 1 to 5 They will also mention the daily analgesic usage
Parameters that will be evaluated by the dermatologist during the study will be tightness of the skin painburning pruritusstinging swellingedema erythema crusting and scaling assessed on a 4-point severity scale 0- best 3- worst
Photographs
Photographs of the patients in 5 angles views will be taken on the day of peel day of mask removal 7 day 28 and after 3 months
The treatment group will recieve 5 consecutive daily hyperbaric treatments 1 hours long each at 2 ATF starting from day 7 to peel Prior to treatment each patient will be signed on informed consent and will have complete physical examination
The control group will be matched by the following parameters age skin color and type and indication for peeling and will be picked up by the dermatologist
Patients will be excluded if they have known middle ear disease chronic lung disease or claustrophobia
Follow -up
The same dermatologist will follow-up on regular dates the follow-up examination will start at day 1 to maskocclusive dressing removal equivalent to day 7 post-peel and at days 7 28 and after 3 months All follow-up examinations will take place at noon 04-08 pm regularly
Efficacy parameters
All patients will be asked to fill up a daily questionnaire on the first week after peel and score the severity of pain pruritus and tightness of facial skin 1 to 5 They will also mention the daily analgesic usage
Parameters that will be evaluated by the dermatologist during the study will be tightness of the skin painburning pruritusstinging swellingedema erythema crusting and scaling assessed on a 4-point severity scale 0- best 3- worst
Photographs
Photographs of the patients in 5 angles views will be taken on the day of peel day of mask removal 7 day 28 and after 3 months
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