Combined Treatment With CO2 Laser and Isotretinoin for Acne Scars
NCT ID: NCT04870489
Last Updated: 2021-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2017-11-01
2022-06-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Isotretinoin + Co2 ablative laser
Isotretinoin treatment while being treated with CO2 laser
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.
Co2 ablative laser
6 months to 1 year without isotretinoin treatments to start second side of face with CO2 ablative laser only
Co2 laser
After 6-12 months of no treatment for acne the patient comes to do second side of face only laser treatment
Interventions
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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.
Co2 laser
After 6-12 months of no treatment for acne the patient comes to do second side of face only laser treatment
Eligibility Criteria
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Inclusion Criteria
* Age 15-60 years old
* Male/Female
* Acne moderate to severe with scarring
* Finished at least 2 months of treatment with Isotretinoin
Exclusion Criteria
* 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
15 Years
60 Years
ALL
Yes
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Eli Sprecher, Professor
Role: STUDY_CHAIR
Tel-Aviv Sourasky Medical Center
Locations
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Tel Aviv sourasky medical center
Tel Aviv, , Israel
Countries
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References
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Waldman A, Bolotin D, Arndt KA, Dover JS, Geronemus RG, Chapas A, Iyengar S, Kilmer SL, Krakowski AC, Lawrence N, Prather HB, Rohrer TE, Schlosser BJ, Kim JYS, Shumaker PR, Spring LK, Alam M. ASDS Guidelines Task Force: Consensus Recommendations Regarding the Safety of Lasers, Dermabrasion, Chemical Peels, Energy Devices, and Skin Surgery During and After Isotretinoin Use. Dermatol Surg. 2017 Oct;43(10):1249-1262. doi: 10.1097/DSS.0000000000001166.
Fife D. Practical evaluation and management of atrophic acne scars: tips for the general dermatologist. J Clin Aesthet Dermatol. 2011 Aug;4(8):50-7.
Tasoula E, Gregoriou S, Chalikias J, Lazarou D, Danopoulou I, Katsambas A, Rigopoulos D. The impact of acne vulgaris on quality of life and psychic health in young adolescents in Greece. Results of a population survey. An Bras Dermatol. 2012 Nov-Dec;87(6):862-9. doi: 10.1590/s0365-05962012000600007.
Strauss JS, Krowchuk DP, Leyden JJ, Lucky AW, Shalita AR, Siegfried EC, Thiboutot DM, Van Voorhees AS, Beutner KA, Sieck CK, Bhushan R; American Academy of Dermatology/American Academy of Dermatology Association. Guidelines of care for acne vulgaris management. J Am Acad Dermatol. 2007 Apr;56(4):651-63. doi: 10.1016/j.jaad.2006.08.048. Epub 2007 Feb 5.
Amichai B, Shemer A, Grunwald MH. Low-dose isotretinoin in the treatment of acne vulgaris. J Am Acad Dermatol. 2006 Apr;54(4):644-6. doi: 10.1016/j.jaad.2005.11.1061.
Goldstein JA, Socha-Szott A, Thomsen RJ, Pochi PE, Shalita AR, Strauss JS. Comparative effect of isotretinoin and etretinate on acne and sebaceous gland secretion. J Am Acad Dermatol. 1982 Apr;6(4 Pt 2 Suppl):760-5. doi: 10.1016/s0190-9622(82)70066-0.
Jones DH, King K, Miller AJ, Cunliffe WJ. A dose-response study of I3-cis-retinoic acid in acne vulgaris. Br J Dermatol. 1983 Mar;108(3):333-43. doi: 10.1111/j.1365-2133.1983.tb03973.x.
Layton AM, Knaggs H, Taylor J, Cunliffe WJ. Isotretinoin for acne vulgaris--10 years later: a safe and successful treatment. Br J Dermatol. 1993 Sep;129(3):292-6. doi: 10.1111/j.1365-2133.1993.tb11849.x.
Abergel RP, Meeker CA, Oikarinen H, Oikarinen AI, Uitto J. Retinoid modulation of connective tissue metabolism in keloid fibroblast cultures. Arch Dermatol. 1985 May;121(5):632-5.
Cruz NI, Korchin L. Inhibition of human keloid fibroblast growth by isotretinoin and triamcinolone acetonide in vitro. Ann Plast Surg. 1994 Oct;33(4):401-5. doi: 10.1097/00000637-199410000-00007.
Sporn MB, Roberts AB, Roche NS, Kagechika H, Shudo K. Mechanism of action of retinoids. J Am Acad Dermatol. 1986 Oct;15(4 Pt 2):756-64. doi: 10.1016/s0190-9622(86)70231-4.
Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.
Chandrashekar BS, Varsha DV, Vasanth V, Jagadish P, Madura C, Rajashekar ML. Safety of performing invasive acne scar treatment and laser hair removal in patients on oral isotretinoin: a retrospective study of 110 patients. Int J Dermatol. 2014 Oct;53(10):1281-5. doi: 10.1111/ijd.12544. Epub 2014 Jul 11.
Layton AM, Henderson CA, Cunliffe WJ. A clinical evaluation of acne scarring and its incidence. Clin Exp Dermatol. 1994 Jul;19(4):303-8. doi: 10.1111/j.1365-2230.1994.tb01200.x.
Other Identifiers
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0629-17
Identifier Type: -
Identifier Source: org_study_id
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