Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04870489
Status:
UNKNOWN
Last Update Posted:
2021-07-13
First Post:
2021-04-12
Brief Title:
Combined Treatment With CO2 Laser and Isotretinoin for Acne Scars
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
Fractional Ablative CO2 Laser Treatment for Acne Scars in Patients Receiving Oral Isotretinoin
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
ACTIVE_NOT_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:
Isotretinoin is an FDA-approved vitamin A metabolite for the treatment of severe acne acne that does not respond to other treatments and has a tendency to cause scarring
Ablative laser treatment is another effective treatment against acne scarring We believe that the combination of CO2 ablative laser treatment with oral isotretinoin for the treatment of scarring is not only safer but also more effective and leads to much more successful cosmetic results
Ablative laser treatment is another effective treatment against acne scarring We believe that the combination of CO2 ablative laser treatment with oral isotretinoin for the treatment of scarring is not only safer but also more effective and leads to much more successful cosmetic results
Detailed Description:
Patients treated with Isotretinoin for at least 2 months with doses ranging from 20 mg-40 mg per day were treated with Co2 ablative laser on one side of the face randomized Patients will be treated with a single session using the fractional AcuPulse CO2 laser AcuPulse Lumenis Inc Santa Clara CA with the AcuScan120 scanner hand-piece and the Deep FX mode The treatment areas will be cleansed with a mild cleanser and 70 alcohol Local anesthesia comprising a topical eutectic mixture of 25 lidocaine hydrochloric acid and 25 prilocaine cream EMLA Cream Astra Zeneca AB Sweden will be applied to the treated side of the face under occlusion before laser therapy After an hour of application the anesthetic cream will gently be removed and then to obtain a completely dry skin surfaceTreatment parameters will be a flounce of 15 mj and density of 15 in single-pass treatment without overlapping pulse Immediately after the treatment gauzes moistened with cold saline solution must be gently applied without rubbing on the skin for 15-20 minutes Thereafter a thin layer of mupirocin 2 ointment TEVA PHARMACEUTICAL INDUSTRIES LTD ISRAEL will be applied on the skin
After the procedure a visual analog scale VAS will be used to determine the amount of pain felt by the participants No pain will be scored as 0 and intolerable pain will be scored as 10 in this scale Photographs will be taken at baseline before each treatment and 6 months after the last treatment Acne scars will be graded by using the Quantitative Global Acne Scarring Grading System which takes into account the quantity and type of scar based on a point system 13 With this grading scale the total score can vary from 0 to 84 The overall score will be determined as the acne scar score All assessments will be done by two independent physicians and the mean value of the two assessments will be calculated A 25 or less decrease in the acne scar score was defined as mild improvement 26-50 decrease as moderate improvement 51-75 decrease as significant improvement and over 75 as near total improvement Lack of decrease in the acne scar score was defined as no change and an increase in the score was defined as worsening
Subjective self-assessment by the participants were done 6 months after the last treatment and was scored as follows - 1 as worsening 0 as no change 1 as mild improvement 2 as moderate improvement 3 as significant improvement and 4 as near total improvement At this point all patients will be 6 months after cessation of oral isotretinoin and will be treated with CO2 laser to the second half of the face with the same treatment parameters All patients will receive CO2 laser treatment once a month for 3 consecutive months LASER treatment will be identical to the treatment mentioned above for the first half of the face
The LASER treatment for the second half of the face will be also evaluated by two independent physicians and will be compared to the first side of the face which was previously treated Both physicians will not be aware as to which side of the face is treated with laser during oral intake of isotretinoin and which side is not
After the procedure a visual analog scale VAS will be used to determine the amount of pain felt by the participants No pain will be scored as 0 and intolerable pain will be scored as 10 in this scale Photographs will be taken at baseline before each treatment and 6 months after the last treatment Acne scars will be graded by using the Quantitative Global Acne Scarring Grading System which takes into account the quantity and type of scar based on a point system 13 With this grading scale the total score can vary from 0 to 84 The overall score will be determined as the acne scar score All assessments will be done by two independent physicians and the mean value of the two assessments will be calculated A 25 or less decrease in the acne scar score was defined as mild improvement 26-50 decrease as moderate improvement 51-75 decrease as significant improvement and over 75 as near total improvement Lack of decrease in the acne scar score was defined as no change and an increase in the score was defined as worsening
Subjective self-assessment by the participants were done 6 months after the last treatment and was scored as follows - 1 as worsening 0 as no change 1 as mild improvement 2 as moderate improvement 3 as significant improvement and 4 as near total improvement At this point all patients will be 6 months after cessation of oral isotretinoin and will be treated with CO2 laser to the second half of the face with the same treatment parameters All patients will receive CO2 laser treatment once a month for 3 consecutive months LASER treatment will be identical to the treatment mentioned above for the first half of the face
The LASER treatment for the second half of the face will be also evaluated by two independent physicians and will be compared to the first side of the face which was previously treated Both physicians will not be aware as to which side of the face is treated with laser during oral intake of isotretinoin and which side is not
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