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A Randomized, Vehicle-Controlled Phase 3 Study of Aminolevulinic Acid Photodynamic Therapy for the Treatment of Actinic Keratoses on the Upper Extremities

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A Randomized, Vehicle-Controlled Phase 3 Study of Aminolevulinic Acid Photodynamic Therapy for the Treatment of Actinic Keratoses on the Upper Extremities A Randomized, Vehicle-Controlled Phase 3 Study of Aminolevulinic Acid Photodynamic Therapy for the Treatment of Actinic Keratoses on the Upper Extremities Shang I. Brian Jiang, MD,* Steven Kempers, MD,† Phoebe Rich, MD,‡ Stuart Marcus, MD, PhD,x Anna Houlihan, MA,║ Daniel Piacquadio, MD,¶ and David Pariser, MD** BACKGROUND Blue-light aminolevulinic acid photodynamic therapy (ALA-PDT) after broad-area application and 3-hour incubation is efficacious for actinic keratosis (AK) lesion clearance on upper extremities, with use of occlusive dressing significantly increasing efficacy. OBJECTIVE To prove the safety and efficacy of ALA-PDT versus vehicle (VEH-PDT) in the spot treatment of multiple AKs on upper extremities. METHODS Aminolevulinic acid or VEH was spot applied only to lesions on one upper extremity 3 hours before blue-light exposure. Treated extremity was covered with occlusive dressing during incubation. Identical treatment was repeated at Week 8 if AK lesions were present in the treated area. RESULTS Thirty-one percent (42/135) of subjects treated with ALA-PDT had complete clearance at Week 12, compared with 13% (17/134) of the subjects treated with VEH-PDT (p = .0001). The mean AK lesion clearance rate for ALA-treated subjects at Weeks 8 and 12 was 53% and 69%, respectively, compared with 26% and 30% for the VEH-treated group (p < .0001, linear mixed model). Safety profile observed in this study is consistent with previous studies/reports in the literature, and the therapy was well tolerated overall. CONCLUSION Aminolevulinic acid-PDT spot treatment using a 3-hour occluded incubation was superior to VEH-PDT for AK lesion clearance of the upper extremity. Supported by DUSA Pharmaceuticals, Inc. The authors have indicated no significant interest with commercial supporters. S.I. Brian Jiang, S. Kempers, P. Rich, and D. Pariser were investigators on the actinic keratosis study presented in this article; S. Marcus and A. Houlihan were employed by DUSA Pharmaceuticals, Inc.; D. Piacquadio is employed by Therapeutics, Inc., the company providing CRO services. ctinic keratoses (AKs) are dysplastic epidermal potential to progress to squamous cell carcinoma Alesions that occur in fair-skinned individuals who (SCC). The results of a published study suggest that have been chronically exposed to sunlight. AKs are AKs may give rise to nonmelanoma skin cancers at a usually found on sun-exposed areas such as the face, greater rate than previously acknowledged.1 Criscione bald scalp, forearms, and backs of hands. Individual and colleagues found, based on following 7,784 AKs are identified as scaly, rough lesions that may individual AKs on the face and ears of 169 disappear and reappear over months or years. AKs are participants, that the risk of progression of AK to considered to be precancerous lesions with the primary SCC was 0.6% at 1 year and 2.57% at 4 *Mohs and Dermatologic Surgery, University of California, San Diego, San Diego, California; †Department of Dermatology, Minnesota Clinical Study Center, University of Minnesota, Fridley, Minnesota; ‡Department of Dermatology, Oregon Dermatology and Research Center, Oregon Health and Science University, Portland, Oregon; xDUSA Pharmaceuticals, Inc., Wilmington, Massachusetts; ║Clinical Research, DUSA Pharmaceuticals, Inc., Wilmington, Massachusetts; ¶Therapeutics, Inc., San Diego, California; **Department of Dermatology, Eastern Virginia Medical School, Virginia Clinical Research, Inc., Norfolk, Virginia © 2019 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved. ISSN: 1076-0512 · Dermatol Surg 2019;00:1–8 · DOI: 10.1097/DSS.0000000000001760 1 © 2019 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. ALA-PDT FOR UPPER-EXTREMITY AKS years; in addition, approximately 65% of all primary 4 weeks after the second treatment were 58.4% 6 SCCs diagnosed during the trial arose in lesions that 22.2% and 24.8% 6 20.6% for the ALA and VEH had earlier been clinically diagnosed as AKs. The sides, respectively. The mean lesion count reduction cellular damage and atypia observed at the histologic for the ALA-treated side was significantly greater than level of AKs is similar to that of surrounding the mean reduction for the VEH-treated side nonlesional skin,2,3 suggesting that skin surrounding (p = .0004). AKs may also be at increased risk of skin cancer. Schmieder and colleagues12 examined the effect of Photodynamic therapy (PDT) using a 20% topical occlusion on ALA-PDT treatment to AKs of the upper solution of aminolevulinic acid-HCl (ALA, Levulan extremities. Seventy subjects were treated with ALA- Kerastick) and activation by 10 J/cm2 blue light (Blue PDT or VEH-PDT using broad-area application and a Light Photodynamic Therapy Illuminator, BLU-U) 3-hour incubation period followed by 10 J/cm2 of blue delivered at 10 mW/cm2 is FDA approved for the spot light; one extremity of each subject was covered with treatment of minimally to moderately thick AKs of the occlusive dressing during the incubation period. The face or scalp after a 14- to 18-hour incubation period median AK lesion clearance rate at Week 12 was (drug-light interval), in the United States and Canada, 88.7% for extremities treated with occluded ALA and the spot treatment of minimally to moderately (ALA + OCC), 70.0% for extremities treated with thick AKs of the upper extremities after a 3-hour nonoccluded ALA, 16.7% for extremities treated with incubation period in the United States. occluded VEH (VEH + OCC), and 5.6% for extrem- ities treated with nonoccluded VEH (p < .0001). When ALA is applied to dysplastic lesions, it is ALA + OCC resulted in a significantly higher lesion absorbed by cells and preferentially metabolized to clearance rate compared with the nonoccluded protoporphyrin IX (PpIX) relative to normally divid- extremity at Week 8 (p = .0006) and Week 12 ing keratinocytes. When PpIX is activated by light of (p = .0029). Thirty-four percent (12/35) of extremities an appropriate wavelength and energy in the presence treated with ALA + OCC had complete clearance of of oxygen, it results in a cytotoxic process. There lesions at Week 12 compared with 0% (0/35) of is minimal damage to surrounding untreated skin, and extremities treated with VEH + OCC (p = .0002). cutaneous photosensitivity is transient (usually clear- ing within 24–48 hours) due to metabolic conversion The current study is designed to prove the safety and of the remaining PpIX to heme.4 efficacy of blue-light ALA-PDT in the treatment of multiple AKs on the upper extremities. ALA-PDT, when used on-label for the 14- to 18-hour incubation, has been shown to be safe and highly Methods effective in the treatment of minimally to moderately 5,6 thick AKs of the face and scalp. There are a few Subjects published studies using ALA and red light7–10 and ALA and blue light11–13 to treat AKs on the arms and hands. Eligible participants were male or nonpregnant, non- lactating females aged 18 years or older, with 4 to 15 Using a bilateral, vehicle-controlled study design, Grade 1 or 2 AKs on one upper extremity (dorsal Taub and Garretson11 treated 15 subjects with at least hand/forearm). Key exclusion criteria included: Grade 3 4 AKs on the dorsal hands/forearms with 2 blue-light and/or atypical AKs within the treatment area; lesions ALA-PDT treatments spaced 8 weeks apart. Amino- suspicious or proven for skin cancer within the treat- levulinic acid or placebo vehicle (VEH) was initially ment area; a history of cutaneous photosensitization; applied to AK lesions, followed by a second applica- any condition with associated immunosuppression; tion to the entire treatment area, occluded with plastic keratolytics including >5% urea, alpha hydroxy acids wrap, and allowed to incubate for 2 hours before blue- (AHAs) (e.g., glycolic acid and >5% lactic acid), >2% light treatment. The mean lesion count reductions salicylic acid within 2 days of initiation of treatment; 2 DERMATOLOGIC SURGERY © 2019 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. BRIAN JIANG ET AL cryotherapy within the previous 2 weeks; topical reti- Outcomes noids within the previous 4 weeks; microdermabrasion, Efficacy end points were complete (100%) clearance ablative laser, ALA-PDT, chemical peels, 5-fluorouracil, rate (CCR) at Weeks 8 and 12, AK lesion clearance diclofenac, imiquimod within the previous 8 weeks; and rate (AKCR) at Weeks 8 and 12 compared with systemic retinoids within the previous 6 months. baseline, and subject satisfaction and acceptability of treatment. Subjects were considered to have complete Procedure clearance if there were no AK lesions present in the Subjects were randomized to receive either ALA or treated area. Tolerability assessments, including ery- VEH as a spot application to AK lesions on one upper thema, edema, scaling and dryness, extremity. The treatment area was defined as the oozing/vesiculation/crusting, and changes in pigmen- dorsal extensor surface of the hand and forearm tation were assessed at each visit using a five-point between the elbow and the base of the fingers (the scale (0 = none to 4 = severe); and stinging/burning was fingers were not included in the treatment area). Before assessed using a four-point scale (0 = none to 3 = application of study solution, the skin was cleansed severe). The evaluating investigator for efficacy was with a mild cleanser, followed by an alcohol wipe. blinded to the treatment assignment. To maintain Two applications of solution were applied to AK blinding, personnel who were not involved in efficacy lesions on the treatment area, and the treatment area assessments administered PDT and assessed for tol- was then covered with an occlusive, polyethylene film, erability to treatment.
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