Evidence-Based Clinical Practice Guidelines for Laser-Assisted Drug Delivery.
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Labadie Jessica G, Ibrahim Sarah A, Worley Brandon, Kang Bianca Y, Rakita Uros, Rigali Sarah, Arndt Kenneth A, Bernstein Eric, Brauer Jeremy A, Chandra Sunandana, Didwania Aashish, DiGiorgio Catherine, Donelan Mattias, Dover Jeffrey S, Galadari Hassan, Geronemus Roy G, Goldman Mitchel P, Haedersdal Merete, Hruza George, Ibrahimi Omar A, Kauvar Arielle, Kelly Kristen M, Krakowski Andrew C, Miest Rachel, Orringer Jeffrey S, Ozog David M, Ross E Victor, Shumaker Peter R, Sobanko Joseph F, Suozzi Kathleen, Taylor Mark B, Teng Joyce M C, Uebelhoer Nathan S, Waibel Jill, Wanner Molly, Ratchev Ina, Christensen Rachel E, Poon Emily, Miller Corinne H, Alam Murad
Аннотация
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.