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Combined Treatment With CO2 Laser and Isotretinoin for Acne Scars

  • Clinicaltrials.gov identifier

    NCT04870489

  • Recruitment Status

    Active, not recruiting

  • First Posted

    May 3, 2021

  • Last update posted

    July 13, 2021

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.

  • Condition or Disease:Acne Vulgaris
  • Intervention/Treatment: Combination Product: Isotretinoin and CO2 laser
    Device: Co2 laser
  • Phase: Phase 2

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.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 30 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Intervention 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) ()
  • Primary Purpose: Treatment
  • Official Title: Fractional Ablative CO2 Laser Treatment for Acne Scars in Patients Receiving Oral Isotretinoin
  • Actual Study Start Date: November 2017
  • Estimated Primary Completion Date: November 2020
  • Actual Study Completion Date: June 2022

Arms and interventions

Arm Intervention/treatment
Active Comparator: Isotretinoin + Co2 ablative laser
Isotretinoin treatment while being treated with CO2 laser
Combination Product: Isotretinoin and CO2 laser
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.
Active Comparator: Co2 ablative laser
6 months to 1 year without isotretinoin treatments to start second side of face with CO2 ablative laser only
Device: Co2 laser
After 6-12 months of no treatment for acne the patient comes to do second side of face only laser treatment

Outcome Measures

  • Primary Outcome Measures: 1. Quantitative Global Acne Scarring Grading System [ Time Frame: Photographs taken at baseline; before each treatment; and 6 months after the last treatment ]
    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"

Eligibility Criteria

  • Ages Eligible for Study: 15 to 60 Years (Child, Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Locations

Israel
Tel Aviv sourasky medical center
Tel Aviv

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

Study Chair: Eli Sprecher, Professor Tel-Aviv Sourasky Medical Center

More Information

  • Layton AM, Henderson CA, Cunliffe WJ. A clinical evaluation of acne scarring and its incidence. Clin Exp Dermatol. 1994 Jul;19(4):303-8.

  • Responsible Party: Tel-Aviv Sourasky Medical Center
  • ClinicalTrials.gov Identifier: NCT04870489 History of Changes
  • Other Study ID Numbers: 0629-17
  • First Posted: May 3, 2021 Key Record Dates
  • Last Update Posted: July 13, 2021
  • Last Verified: April 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • 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
  • 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.: Yes
  • Keywords provided by Tel-Aviv Sourasky Medical Center: acne vulgaris;scars; CO2 laser; ISOTRETINOIN;treatments
  • Additional relevant MeSH terms: Acne Vulgaris
    Acneiform Eruptions
    Skin Diseases
    Sebaceous Gland Diseases