Clinical Research at Wilmington Dermatology Center

• A Randomized, Double-Blind, Vehicle-Controlled, Phase 2 Trial to Evaluate the Anti-Pruritic Efficacy, Safety, Tolerability, and Pharmacokinetics of ASN008 in Adults with Mild to Moderate Atopic Dermatitis. TrialSpark, Inc. 2023. Principal Investigator.
• A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ANB032 in Treatment of Subjects with Moderate to Severe Atopic Dermatitis. AnaptysBio, Inc. 2023. Principal Investigator.
• A randomized, no-treatment-control, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane Contour in the treatment of temple hollowing. Q-Med AB, Galderma 2023. Principal Investigator.
• Publication: JDD June 2023 – Volume 22 – Issue 6: Reduction of Erythema in Moderate-Severe Rosacea by a Low Molecular Weight Heparan Sulfate Analog (HSA). Rosalyn George MD, Richard L. Gallo MD PhD, Joel L. Cohen MD, Madeline Brown BS, Chidubem A. V. Okeke BS, Angel S. Byrd MD PhDA
• Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of VTX958 in Participants with Moderate-to-severe Psoriasis. Ventyx Biosciences 2023. Principal Investigator.
• A Phase 3, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab Monotherapy in Adult Subjects With Moderate-to-severe AD (ROCKET-Ignite). Amgen Inc. 2023. Principal Investigator.
• A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants with Moderate to Severe Plaque Psoriasis with Randomized Withdrawal and Retreatment.Janssen Research & Development, LLC. 2023. Principal Investigator.
• A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND).Amgen Inc. 2023. Principal Investigator.

• A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of Cedirogant (ABBV-157) in Adult Subjects with Moderate to Severe Psoriasis. AbbVie Inc. 2022. Principal Investigator.
• Publication: George, R et al. A Randomized Trial to Assess Effectiveness and Safety of a Hyaluronic Acid Filler for Chin Augmentation and Correction of Chin Retrusion Plastic and Reconstructive Surgery: PRS Journal, Sept 2022
• A Phase 2b, Multicenter, Randomized, Double-Blind, VehicleControlled, Parallel-Group Study to Determine the Safety, Tolerability, Pharmacokinetics, and Efficacy of ATI-1777 in Patients 12 to 65 Years Old with Moderate or Severe Atopic Dermatitis (AD). Aclaris Therapeutics, Inc. 2022. Principal Investigator.
• A Multicenter, Randomized, Double-Blind, Parallel-Group, Active and Placebo-Controlled Study to Assess the Safety, Efficacy, and Tolerability of Oral DFD-29 Extended Release Capsules for the Treatment of Inflammatory Lesions of Rosacea Over 16 Weeks. Dr. Reddy’s Laboratories Ltd. 2022. Principal Investigator.
• A Phase 3, Multicenter Study to Evaluate the Safety and Efficacy of AGN-151586 for the Treatment of Glabellar Lines in Toxin-Naïve Subjects. AbbVie Inc. 2022. Principal Investigator.
  Development of Patient Reported Outcome Measures in Fine Lines- Mixed Concept Elicitation and Cognitive Interviews. Allergan PLC. 2022.
• A Multicenter, Double-Blind, Randomized, Placebo-Controlled Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of OnabotulinumtoxinA X for the Treatment of Moderate to Severe Glabellar Lines. AbbVie Inc. 2022. Principal Investigator.

• A Phase 2B, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Efficacy, Safety, and Tolerability of NDI-034858 in Subjects with Moderate to Severe Plaque Psoriasis. Nimbus Lakshmi, Inc. 2021. Principal Investigator.
• A Multicenter, Randomized, Double-blind Study Evaluating the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Multiple Switches Between Humira® (adalimumab [US]) and ABP 501 Compared with Continued Use of Adalimumab in Subjects with Moderate to Severe Plaque Psoriasis. Amgen, Inc. 2021. Principal Investigator.
• A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 24-Week Study, with a 28-Week Open-Label Extension, to Assess the Safety and Efficacy of Etrasimod in Subjects with Moderate-to-Severe Alopecia Areata. Arena Pharmaceuticals, Inc. 2021. Principal Investigator.
• A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence. AbbVie, 2021. Principal Investigator.
• Prospective, evaluator-blind, multicenter study to assess the safety and effectiveness of the Octave System treatment for improving lines and wrinkles on the décolleté. Ulthera. 2021. Principal Investigator.
• A Multicenter, Randomized, Double-blind, Vehicle-Controlled, Phase 2a Study of TER-101 2.75% Topical Ointment to Assess Efficacy and Safety in Subjects with Mild to Moderate Atopic Dermatitis. Teres Bio., 2021. Principal Investigator.

• A Multicenter, Randomized, Double-blinded Study Evaluating the Pharmacokinetics, Efficacy and Safety of Multiple Switches Between Ustekinumab and ABP 654 Compared with Continued Use of Ustekinumab in Subjects with Moderate to Severe Plaque Psoriasis. Amgen Inc. 2020. Principal Investigator.
• A Phase 3, Multicenter, Randomized, Double-Blind Study Evaluating the Efficacy and Safety of ABP 654 Compared with Ustekinumab in Subjects with Moderate to Severe Plaque Psoriasis. Amgen, Inc. 2020. Principal Investigator.
• A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab when used in combination with Topical Corticosteroid Treatment in Patients with Moderate-to-Severe Atopic Dermatitis. Dermira Inc, 2020. Principal Investigator.
• A Long-Term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients with Moderate-to-Severe Atopic Dermatitis. Dermira Inc, 2020. Principal Investigator.
• A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects. Galderma Research and Development, 2020. Principal Investigator.
• A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of MT10109L for the Treatment of Lateral Canthal Lines with or Without Concurrent Treatment of Glabellar Lines. Allergan, 2020. Principal Investigator.
• A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Glabellar Lines. Galderma, 2020. Principal Investigator.
• Development of Patient Reported Outcome Measures in Fine Lines – Mixed Concept of Elicitation and Cognitive Interviews (AGN 1418). Allergan PLC, 2020. Principal Investigator.

• A Random, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients with Moderate-to-severe atopic dermatitis. Dermira, 2019. Principal Investigator.
• A Randomized, evaluator-blinded, parallel group, no treatment controlled multi-center study to evaluate the safety and effectiveness of Restylane-L for correction of Infraorbital Hollows. Galderma. 2019. Principal Investigator.
• A Phase 2b Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of AGN-151586 in Participants with Moderate to Severe Glabellar Lines. Allergan. 2019. Principal Investigator.
• A Phase 3 Efficacy and Safety Study of Tapinarof Topical for the Treatment of Plaque Psoriasis in Adults. Dermavant Sciences GmbH. 2019. Principal Investigator.
• A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Risankizumab Using a New Formulation for the Treatment of Adult Subjects with Moderate to Severe Plaque Psoriasis. Abbvie. 2019. Principal Investigator.
• A Phase 2, randomized, placebo-controlled, double-blind, multiple dose study to evaluate the efficacy and safety of ANB019 in subjects with Palmoplantar Pustulosis. AnaptysBio Inc. 2019. Principal Investigator.
• A Phase 2b, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study investigating the efficacy, safety, and pharmacokinetic profiles of REGN3500 administered to adult patients with moderate-to-severe atopic dermatitis. Regeneron Pharmaceuticals, Inc. 2019. Principal Investigator.

• A phase II, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Calcipotriene and Betamethasone Dipropionate Topical Foam to the Marketed Product Enstilar Foam in the Treatment of Psoriasis Vulgaris. Glenmark Pharmaceuticals, 2018. Principal Investigator.
• A Randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of topical tranexamic acid in a novel transdermal delivery system for improvement of melasma. Dyve Biosciences, 2018. Principal Investigator.
• A Randomized, No-Treatment Controlled, Evaluator-Blinded, Multicenter Study to Evaluate the Effectiveness and Safety of Restylane® Defyne in the Chin for Augmentation and Correction of Chin Retrusion. Nestle Skin Health, 2018. Principal Investigator.
• A Multicenter, Randomized, Double-Blind, Secukinumab-controlled, parallel-group study to evaluate the efficacy and safety of Bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis. UCB Biosciences, 2018. Principal Investigator.
• A Randomized, Double-Blind, Placebo-Controlled, efficacy study of the Neurokinin-1 receptor antagonist VLY-686 in patients with Atopic Dermatitis. VANDA, 2018. Principal Investigator.
• A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging study investigating the Efficacy, Safety and Pharmacokinetic Profile of ANB020 Administered to Adult Subjects with Moderate-to-Severe Atopic Dermatitis. AnaptsysBio, 2018. Principal Investigator.
• A Randomized, Double-Blind, Placebo-controlled, Dose-ranging trial to evaluate the efficacy and safety of Lebrikizumab in patients with Moderate-to-severe Atopic Dermatitis. Dermira, 2018. Principal Investigator.
• Efficacy, Safety and Durability of Response of BMS-986165 Versus Placebo and Active Comparator in Subjects with Moderate-to-Severe Plaque Psoriasis. BMS, 2018. Principal Investigator.
• A Randomized, Double-Blind, Placebo-controlled, Multicenter, 24-week Study to Assess the Efficacy and Safety of PPC-06 (Teplilamide Fumarate) Extended Release Tablets in Subjects with Moderate-to-Severe Plaque Psoriasis. Novella, 2018. Principal Investigator.

• Randomized, Double-Blind Comparison Pilot Study Evaluating the Safety and Efficacy of Tranexamic Acid, in a Novel Transdermal Delivery System, Compared to Hydroquinone for Improvement of Melasma. AmperSand Biopharmaceuticals, LLC 2017. Principal Investigator.
• Double-Blind, Controlled, Pilot Study Evaluating the Safety and Efficacy of Percorium-Delivered Bimatoprost and Minoxidil for the Treatment of Alopecia Androgenetica (Male Pattern Hair Loss). AmperSand Biopharmaceuticals, LLC 2017. Principal Investigator.
• A Multicenter, Open Label Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis. AbbVie 2017. Principal Investigator.

• A Multicenter, Randomized, Double-Blind Placebo-Controlled, Parallel-Group, Dose Ranging Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Bimekizumab in Adult Subjects with Moderate to Severe Chronic Plaque Psoriasis. UCB Biosciences, Inc. 2016. Principal Investigator.
• A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of Halobetasol Propionate Foam, 0.05% Versus Vehicle Foam In Subjects with Plaque Psoriasis. Therapeutics 2016. Principal Investigator.
• Non-Inferiority Study of the Safety and Efficacy of Ultherapy for Lifting and Tightening the Face and Neck Using Standard vs. Simulines Transducers. Ulthera Inc. 2016. Principal Investigator
• BI 655066 versus Ustekinumab and placebo comparators in a randomized double-blind trial for Maintenance use in Moderate to severe plaque type psoriasis-2 (UltMMa-2). Boehringer Ingelheim Pharmaceuticals, Inc. 2016. Principal Investigator.
• A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Tadipitant in Treatment-Resistant Pruritus Associated with Atopic Dermatitis. Vanda Pharmaceuticals Inc. 2016. Principal Investigator.
• A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Generics, Ltd) to the Marketed Product Protopic (tacrolimus) ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis. Novum Pharmaceutical Research Services, 2016. Principal Investigator.

• Pilot Study Site: Non-Inferiority Study of the Safety and Efficacy of Ultherapy for Lifting and Tightening the Face and Neck Using Standard vs. Simulines Transducers. Ulthera Inc. 2015. Principal Investigator.
• A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients with Moderate-to-Severe Plaque Psoriasis. Lilly USA LLC. 2015. Principal Investigator.
• A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 1.5mg/kg per Day or Sarecycline Compared to Placebo in the Treatment of Acne Vulgaris. Actavis. 2015. Principal Investigator.
• Multi-center non-interventional study to collect information on the condition of submental (SM) fullness due to submental fat (SMF), how it is treated in current clinical practice, and the risks and benefits associated with its treatment. Kythera Biopharmaceuticals, Inc. 2015. Principal Investigator.
• A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients with Moderate-to-Severe Atopic Dermatitis. Regeneron Pharmaceuticals, Inc. 2015. Principal Investigator.
• A Multi-center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo New York Inc’s Ingenol Mebutate Topical Gel 0.05% to Leo Pharma Inc. Picato Topical Gel 0.05% (Ingenol Mebutate Topical Gel 0.05%) and Both Active Treatment to a Vehicle Control in the Treatment of Actinic Keratosis on the Trunk and Extremities. Perrigo New York, Inc.,2015. Principal Investigator.
• A Randomized, Double-Blind, Parallel Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Gel 3% (Taro Pharmaceuticals USA., Inc.) Compared to Solaraze 3%, gel (diclofenac sodium 3% w/ Almirall, S.A.) in the Treatment of Actinic Keratosis. Novum Pharmaceutical Research Services, 2015. Principal Investigator.
• Evaluation of the safety and efficacy of the Ulthera System for the treatment of signs and symptoms of Erythemototelangiectatic Rosacea. Ulthera Inc. 2015. Principal Investigator.

• Vacation Dermatoses. Jessica Connett, MD and Rosalyn George, MD, JAAD Vol 70, Num 5, 961-963, May 2014.
• A Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group, Study followed by a dose-blind period and open-label follow-up to evaluate the efficacy and safety of Certolizumab Pegol in subjects with moderate to severe chronic plaque psoriasis. Dermira. 2014. Principal Investigator.
• A Randomized double-blind, multicenter study to demonstrate equivalent efficacy and to compare safety and immunogenicity of a biosimilar adalimumab and Humira in patients with moderate to severe chronic plaque-type psoriasis. Sandoz. 2014. Principal Investigator.
• A Safety and Efficacy Study to Compare Dapsone Dermal Gel with Vehicle Control in Patients with Acne Vulgaris. Allergan. 2014. Principal Investigator.
• An Observational, multicenter disease registry to evaluate clinical practice trends and outcomes in adult patients with Hidradenitis Suppurativa. AbbVie Inc. 2014. Principal Investigator.

• A Multicenter, Randomized, Double-Blind, Parallel Group Comparison of Halobetasol Propionate Lotion 0.05% versus Vehicle Lotion in Subjects with Plaque Psoriasis. Therapeutics. 2013. Principal Investigator.
• A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to determine the Therapeutic Equivalence of Generic Imiquimod Cream, 2.5% and Zyclara (Imiquimod) Cream 2.5% in Subjects with Actinic keratoses. Therapeutics. 2013. Principal Investigator.
• A Randomized, Vehicle-Controlled, Double-Blind, Parallel-Group, Multi-Center Phase III Study to Evaluate the Safety and Efficacy of M518101 in Subjects with Plaque Psoriasis. Maruho North America. 2013. Principal Investigator.
• A Randomized, Double-Blind, Multiple-Site, Placebo-controlled, Parallel Design Study comparing Diclofenac Sodium Gel 3% (Actavis) to Solaraze (diclofenac) Gel 3% in the Treatment of Actinic Keratosis. Actavis. 2013. Principal Investigator.

• A Multi-center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients with Moderate to Severe Plaque Psoriasis. Eli lilly Co. 2012 to present. Principal Investigator.

• A 10-Year, Post-marketing, Observational, Registry of HUMIRA (Adalimumab) in Adult Patients with Chronic Plaque Psoriasis (Ps). Abbott Laboratories. December 2011 to present. Principal Investigator.
• An Evaluation of the Burden of Illness Among Adults with Moderate-to-Severe Plaque Psoriasis Seeking Care in the United States. Pfizer. 2011- 2012. Principal Investigator.
• A Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Center Phase IIb Dose Finding Study of M518101 in Plaque Psoriasis Patients. Maruho Co., Ltd. 2011 2012. Principal Investigator.

• Efficacy and Safety of Alitretinoin in the Treatment of Severe chronic Hand Eczema Refractory to Topical Therapy. Basilea Pharmaceuticals. June 2009-Present. Principal Investigator.

George R, Clarke S, Ioffreda M, Billingsley E. Marking of nail matrix biopsies with ink aids in proper specimen orientation for more accurate histologic evaluation. Dermatologic Surgery Vol 32, number 12, 1705-1706, Dec 2008.

• Study on interest in cosmetic procedures in patients visiting an academic dermatology group. Penn State Milton S. Hershey Medical Center, 2007
• Clarke S, Nelson A, George R, Thiboutot D. Pharmacologic Modulation of Sebaceous Gland Activity: Mechanism’s and Clinical Applications. Dermatologic Clinics: Drug Actions, Reactions and Interactions. Dermatologic Clinics. April 2007
• Rosalyn George, MD, Gregory J. Fulchiero, Jr, MD, MSBioEng, James G. Marks, Jr, MD, Jennie T. Clarke, MD. Neurovascular Instability Syndrome: A Unifying Term to Describe the Coexistence of Temperature-Related Vascular Disorders in Affected Patients. Arch of Dermatol Vol 143, 274-275, (2007).
• Jennie T. Clarke MD, Harper Price MD, Shari Clarke MD, Rosalyn George MD, Jeffrey J. Miller MD. Case Reports: Acquired Kinking of the Hair Caused by Acitretin. Journal of Drugs in Dermatology Vol 6, Issue 9, 937-938 (2007).

• Study to determine the ideal biopsy site for lentigo maligna. Penn State Milton S. Hershey Medical Center, 2006-present
• George R. Commentary on May 2007 JAAD article Two randomized phase III clinical trials evaluating anti-inflammatory dose doxycycline (40-mg doxycycline, USP capsules) administered once daily for treatment of rosacea. Published on Dermlink.net
• George R. Commentary on September 2006 NEJM article Sentinel-node biopsy or nodal observation in melanoma. Published on Dermlink.net

• Populous Papules. George R, Nunley J., Cortlandt Forum 2003;16(8): 46-49.

• Study on the effects of P450 enzymes in the conversion of chlorpyrifos to chlorpyrifos-oxon. Virginia Maryland Regional College of Veterinary Medicine, 1998-1999