Clinical trial NCT00425789: Hyperbaric Therapy and Deep Chemical Peeling
Official title: Hyperbaric Therapy and Healing From Deep Chemical Peel
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Chemical Peeling
Keywords: Deep Chemical Peeling
Hyperbaric Therapy
post-deep peel
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-01-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 peel.Patient's 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 mask\\occlusive 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, pain/burning, pruritus/stinging, swelling/edema, 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.

Eligibility criteria: Inclusion Criteria:

* The study will include 40 post-deep peel women (exoderm), older than 18 years old, treated by the same dermatologist (dr. Landau).
* The treatment group will receive 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.

Exclusion Criteria:

* Patients will be excluded if they have known middle ear disease, chronic lung disease or claustrophobia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Research & Development Unit, Assaf-Harofeh Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Tal Friedman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assaf-Harofeh Medical Center
name: Shai Efrati, MD
role: STUDY_DIRECTOR
References: