TY - JOUR

T1 - Evidence-Based Clinical Practice Guidelines for Laser-Assisted Drug Delivery

AU - Labadie, Jessica G.

AU - Ibrahim, Sarah A.

AU - Worley, Brandon

AU - Kang, Bianca Y.

AU - Rakita, Uros

AU - Rigali, Sarah

AU - Arndt, Kenneth A.

AU - Bernstein, Eric

AU - Brauer, Jeremy A.

AU - Chandra, Sunandana

AU - Didwania, Aashish

AU - Digiorgio, Catherine

AU - Donelan, Mattias

AU - Dover, Jeffrey S.

AU - Galadari, Hassan

AU - Geronemus, Roy G.

AU - Goldman, Mitchel P.

AU - Haedersdal, Merete

AU - Hruza, George

AU - Ibrahimi, Omar A.

AU - Kauvar, Arielle

AU - Kelly, Kristen M.

AU - Krakowski, Andrew C.

AU - Miest, Rachel

AU - Orringer, Jeffrey S.

AU - Ozog, David M.

AU - Ross, E. Victor

AU - Shumaker, Peter R.

AU - Sobanko, Joseph F.

AU - Suozzi, Kathleen

AU - Taylor, Mark B.

AU - Teng, Joyce M.C.

AU - Uebelhoer, Nathan S.

AU - Waibel, Jill

AU - Wanner, Molly

AU - Ratchev, Ina

AU - Christensen, Rachel E.

AU - Poon, Emily

AU - Miller, Corinne H.

AU - Alam, Murad

N1 - Publisher Copyright: © 2022 American Medical Association. All rights reserved.

PY - 2022

Y1 - 2022

N2 - Importance: Laser-assisted drug delivery (LADD) is used for various medical and cosmetic applications. However, there is insufficient evidence-based guidance to assist clinicians performing LADD. Objective: To develop recommendations for the safe and effective use of LADD. Evidence Review: A systematic literature review of Cochrane Central Register of Controlled Trials, Embase, and MEDLINE was conducted in December 2019 to identify publications reporting research on LADD. A multidisciplinary panel was convened to draft recommendations informed by the systematic review; they were refined through 2 rounds of Delphi survey, 2 consensus meetings, and iterative review by all panelists until unanimous consensus was achieved. Findings: Of the 48 published studies of ablative fractional LADD that met inclusion criteria, 4 were cosmetic studies; 21, oncologic; and 23, medical (not cosmetic/oncologic), and 6 publications of nonablative fractional LADD were included at the request of the expert panel, producing a total of 54 studies. Thirty-four studies (63.0%) were deemed to have low risk of bias, 17 studies (31.5%) had moderate risk, and 3 (5.5%) had serious risk. The key findings that informed the guidelines developed by the expert panel were as follows: LADD is safe in adults and adolescents (≥12 years) with all Fitzpatrick skin types and in patients with immunosuppression; it is an effective treatment for actinic keratosis, cutaneous squamous cell carcinoma in situ, actinic cheilitis, hypertrophic scars, and keloids; it is useful for epidermal and dermal analgesia; drug delivery may be increased through the application of heat, pressure, or occlusion, or by using an aqueous drug solution; laser settings should be selected to ensure that channel diameter is greater than the delivered molecule; antibiotic prophylaxis is not recommended, except with impaired wound healing; antiviral prophylaxis is recommended when treating the face and genitalia; and antifungal prophylaxis is not recommended. The guideline's 15 recommendations address 5 areas of LADD use: (I) indications and contraindications; (II) parameters to report; (III) optimization of drug delivery; (IV) safety considerations; and (V) prophylaxis for bacterial, viral, and fungal infections. Conclusions and Relevance: This systematic review and Delphi consensus approach culminated in an evidence-based clinical practice guideline for safe and effective use of LADD in a variety of applications. Future research will further improve our understanding of this novel treatment technique.

AB - Importance: Laser-assisted drug delivery (LADD) is used for various medical and cosmetic applications. However, there is insufficient evidence-based guidance to assist clinicians performing LADD. Objective: To develop recommendations for the safe and effective use of LADD. Evidence Review: A systematic literature review of Cochrane Central Register of Controlled Trials, Embase, and MEDLINE was conducted in December 2019 to identify publications reporting research on LADD. A multidisciplinary panel was convened to draft recommendations informed by the systematic review; they were refined through 2 rounds of Delphi survey, 2 consensus meetings, and iterative review by all panelists until unanimous consensus was achieved. Findings: Of the 48 published studies of ablative fractional LADD that met inclusion criteria, 4 were cosmetic studies; 21, oncologic; and 23, medical (not cosmetic/oncologic), and 6 publications of nonablative fractional LADD were included at the request of the expert panel, producing a total of 54 studies. Thirty-four studies (63.0%) were deemed to have low risk of bias, 17 studies (31.5%) had moderate risk, and 3 (5.5%) had serious risk. The key findings that informed the guidelines developed by the expert panel were as follows: LADD is safe in adults and adolescents (≥12 years) with all Fitzpatrick skin types and in patients with immunosuppression; it is an effective treatment for actinic keratosis, cutaneous squamous cell carcinoma in situ, actinic cheilitis, hypertrophic scars, and keloids; it is useful for epidermal and dermal analgesia; drug delivery may be increased through the application of heat, pressure, or occlusion, or by using an aqueous drug solution; laser settings should be selected to ensure that channel diameter is greater than the delivered molecule; antibiotic prophylaxis is not recommended, except with impaired wound healing; antiviral prophylaxis is recommended when treating the face and genitalia; and antifungal prophylaxis is not recommended. The guideline's 15 recommendations address 5 areas of LADD use: (I) indications and contraindications; (II) parameters to report; (III) optimization of drug delivery; (IV) safety considerations; and (V) prophylaxis for bacterial, viral, and fungal infections. Conclusions and Relevance: This systematic review and Delphi consensus approach culminated in an evidence-based clinical practice guideline for safe and effective use of LADD in a variety of applications. Future research will further improve our understanding of this novel treatment technique.

UR - http://www.scopus.com/inward/record.url?scp=85137110575&partnerID=8YFLogxK

U2 - 10.1001/jamadermatol.2022.3234

DO - 10.1001/jamadermatol.2022.3234

M3 - Review

C2 - 35976634

AN - SCOPUS:85137110575

VL - 158

SP - 1193

EP - 1201

JO - JAMA Dermatology

JF - JAMA Dermatology

SN - 2168-6068

IS - 10

ER -