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Combined Treatment With CO2 Laser and Isotretinoin for Acne Scars

Primary Purpose

Acne Vulgaris

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Isotretinoin and CO2 laser
Co2 laser
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne vulgaris;scars; CO2 laser; ISOTRETINOIN;treatments

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy individuals
  • Age 15-60 years old
  • Male/Female
  • Acne moderate to severe with scarring
  • Finished at least 2 months of treatment with Isotretinoin

Exclusion Criteria:

  • Prior laser treatment for acne scarring
  • Patients that have a tendency to have abnormal scarring
  • Patients that are immunosuppressed or patients receiving immunosuppressive treatment
  • Prior radiotherapy treatment to affected area
  • Infected acne
  • Rosacea

Sites / Locations

  • Tel Aviv sourasky medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Isotretinoin + Co2 ablative laser

Co2 ablative laser

Arm Description

Isotretinoin treatment while being treated with CO2 laser

6 months to 1 year without isotretinoin treatments to start second side of face with CO2 ablative laser only

Outcomes

Primary Outcome Measures

Quantitative Global Acne Scarring Grading System
With this acne scars grading scale, the total score can vary from 0 to 84. The overall score will be determined as the "acne scar score". 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"

Secondary Outcome Measures

Full Information

First Posted
April 12, 2021
Last Updated
July 11, 2021
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04870489
Brief Title
Combined Treatment With CO2 Laser and Isotretinoin for Acne Scars
Official Title
Fractional Ablative CO2 Laser Treatment for Acne Scars in Patients Receiving Oral Isotretinoin
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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 2.5% lidocaine hydrochloric acid and 2.5% 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 surface.Treatment 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne vulgaris;scars; CO2 laser; ISOTRETINOIN;treatments

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Patients are treated with Isotretinoin for at least 2 months prior to starting Co2 laser treatment, then they receive laser treatment on one side of the face (randomized) while still taking Isotretinoin; 6 months after cessation of Isotretinoin or any other treatment they are then treated with Co2 laser only on the second side of the face
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Isotretinoin + Co2 ablative laser
Arm Type
Active Comparator
Arm Description
Isotretinoin treatment while being treated with CO2 laser
Arm Title
Co2 ablative laser
Arm Type
Active Comparator
Arm Description
6 months to 1 year without isotretinoin treatments to start second side of face with CO2 ablative laser only
Intervention Type
Combination Product
Intervention Name(s)
Isotretinoin and CO2 laser
Intervention Description
Patients must complete at least 2 months of Isotretinoin prior to starting the study and then continue it for the duration of the 3 months of treatment with the CO2 laser.
Intervention Type
Device
Intervention Name(s)
Co2 laser
Intervention Description
After 6-12 months of no treatment for acne the patient comes to do second side of face only laser treatment
Primary Outcome Measure Information:
Title
Quantitative Global Acne Scarring Grading System
Description
With this acne scars grading scale, the total score can vary from 0 to 84. The overall score will be determined as the "acne scar score". 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"
Time Frame
Photographs taken at baseline; before each treatment; and 6 months after the last treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy individuals Age 15-60 years old Male/Female Acne moderate to severe with scarring Finished at least 2 months of treatment with Isotretinoin Exclusion Criteria: Prior laser treatment for acne scarring Patients that have a tendency to have abnormal scarring Patients that are immunosuppressed or patients receiving immunosuppressive treatment Prior radiotherapy treatment to affected area Infected acne Rosacea
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eli Sprecher, Professor
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Tel Aviv sourasky medical center
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
sex, age, acne severity, acne disease duration, accumulated isotretinoin dose prior to co2 laser and at the end of treatment, VAS score, skin type, weight, medical history
Citations:
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Combined Treatment With CO2 Laser and Isotretinoin for Acne Scars

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