Combined Treatment With CO2 Laser and Isotretinoin for Acne Scars

NCT04870489 | Unknown Phase 2

• 1 other identifier: 0629-17
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Keywords

acne vulgaris;scars; CO2 laser; ISOTRETINOIN;treatments

Outcome Measures

Primary Outcomes (1)

• 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"

  Photographs taken at baseline; before each treatment; and 6 months after the last treatment

Study Arms (2)

Isotretinoin + Co2 ablative laser

ACTIVE COMPARATOR

Isotretinoin treatment while being treated with CO2 laser

Combination Product: Isotretinoin and CO2 laser

Co2 ablative laser

ACTIVE COMPARATOR

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

Device: Co2 laser

Interventions

Isotretinoin and CO2 laser COMBINATION_PRODUCT

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.

Isotretinoin + Co2 ablative laser

Co2 laser DEVICE

After 6-12 months of no treatment for acne the patient comes to do second side of face only laser treatment

Co2 ablative laser

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv sourasky medical center

Tel Aviv, Israel

Location

Related Publications (14)

• 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.

  PMID: 28498204 BACKGROUND

• 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.

  PMID: 21909457 BACKGROUND

• 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.

  PMID: 23197205 BACKGROUND

• 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.

  PMID: 17276540 BACKGROUND

• 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.

  PMID: 16546586 BACKGROUND

• 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.

  PMID: 6461679 BACKGROUND

• 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.

  PMID: 6219690 BACKGROUND

• 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.

  PMID: 8286227 BACKGROUND

• 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.

  PMID: 3994409 BACKGROUND

• 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.

  PMID: 7810956 BACKGROUND

• 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.

  PMID: 3021829 BACKGROUND

• 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.

  PMID: 15216537 BACKGROUND

• 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.

  PMID: 25039864 BACKGROUND

• 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.

  PMID: 7955470 RESULT

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Isotretinoin; Lasers, Gas

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Eli Sprecher, Professor

  Tel-Aviv Sourasky Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: May 3, 2021
• Study Start: November 1, 2017
• Primary Completion: November 30, 2020
• Study Completion: June 1, 2022
• Last Updated: July 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)