Kenneth J Washenik, M.D., Ph.D.

Comparison of tazarotene and minocycline maintenance therapies in acne vulgaris: a multicenter, double-blind, randomized, parallel-group study
Leyden, James; Thiboutot, Diane M; Shalita, Alan R; Webster, Guy; Washenik, Kenneth; Strober, Bruce E; Shupack, Jerome
2006 May;142(5):605-612, Archives of dermatology
OBJECTIVE: To evaluate the efficacy of 3 maintenance regimens (topical tazarotene, oral minocycline hydrochloride, or both) in sustaining improvement in acne. DESIGN: Multicenter, open-label treatment phase followed by double-blind, randomized, parallel-group maintenance phase. SETTING: Ambulatory patients in research or referral centers. PATIENTS: Volunteer sample of 189 patients with moderately severe to severe acne vulgaris (110 entered maintenance phase, 90 completed, and 2 discontinued because of adverse events). INTERVENTIONS: All patients were treated with 0.1% tazarotene gel (each evening) and a 100-mg capsule (twice daily) of minocycline hydrochloride for up to 12 weeks. Patients with 75% or greater global improvement at week 12 were randomly assigned to 12 weeks of maintenance therapy with tazarotene gel plus placebo capsules, vehicle gel plus minocycline capsules, or tazarotene gel plus minocycline capsules. MAIN OUTCOME MEASURES: Overall disease severity, global improvement, and lesion counts. RESULTS: All regimens were effective in sustaining improvements in acne. After 12 weeks of maintenance therapy, the mean reductions from baseline in noninflammatory and inflammatory lesion count, respectively, were 60% and 54% with tazarotene, 52% and 66% with minocycline, and 64% and 66% with tazarotene plus minocycline. At week 24, more than 80% of patients in each group had maintained a 50% or greater global improvement from baseline, and more than 50% had maintained a 75% or greater global improvement. CONCLUSIONS: A high percentage of patients with moderately severe to severe acne can maintain improvement in their condition with topical retinoid monotherapy. Maintenance with combination tazarotene and minocycline therapy showed a trend for greater efficacy but no statistical significance vs tazarotene alone. Topical retinoid monotherapy should be considered for maintenance to help minimize antibiotic exposure
— id: 94895, year: 2006, vol: 142, page: 605, stat: Journal Article,

Topical retinoids in inflammatory acne: A retrospective, investigator-blinded, vehicle-controlled, photographic assessment
Leyden, JJ; Shalita, A; Thiboutot, D; Washenik, K; Webster, G
2005 FEB ;27(2):216-224, Clinical therapeutics
Background: Despite published data showing the efficacy of topical retinoids in treating inflammatory acne, in clinical practice topical retinoids tend to be used most commonly for noninflammatory acne. Objective: The goal of this study was to assess the efficacy of topical retinoids as monotherapy in inflammatory acne. Methods: This retrospective, Investigator-blinded, vehicle-controlled, photographic assessment study was conducted by 5 investigators. The investigators rated pretreatment and posttreatment photographs of patients who had participated in 12- or 15-week, double-blind comparisons of tazarotene 0.1% gel, adapalene 0.1% gel, tretinoin 0.1% microsponge, tretinoin 0.025% gel, and tazarotene 0.1% cream (vehicle). Acne severity was rated on a 7-point scale. A posttreatment increase or decrease of 1 grade was considered clinically meaningful; >= 2 grades was considered an even clearer measure of clinically significant improvement. Investigators also rated global response to treatment on a 7-point scale. A posttreatment increase of >= 2 grades was considered a clinically relevant improvement. Results: Each of the 5 investigators rated photographs of 577 patients (similar to 52% women, similar to 48% men; mean age, 18-20 years), for a total of 2885 evaluations (in addition to daily evaluations of the 20 control patients). The treatment groups consisted of tazarotene (252 patients, 1260 evaluations), adapalene (178 patients, 890 evaluations), tretinoin microsponge (47 patients, 235 evaluations), tretinoin gel (39 patients, 195 evaluations), and vehicle (61 patients, 305 evaluations). Inflammatory acne was improved with all 4 retinoids compared with vehicle. In 1905 evaluations in which pretreatment acne severity was grade 3 (mild to moderate), the incidences of clinically significant improvements In the tazarotene, adapalene, and tretinoin microsponge groups were 24%, 17%, and 21%, respectively (all, P <= 0.001 vs vehicle [7%]). The difference in prevalence of clinically significant improvement was statistically similar between the tretinoin gel and vehicle groups. The incidences of clinically relevant improvement in global response to tazarotene, adapalene, tretinoin microsponge, and tretinoin gel were 36%, 34%, 31%, and 28%, respectively (P <= 0.001, <= 0.001, <= 0.001, and <= 0.01, respectively, vs vehicle [17%]). Conclusions: The results of this study suggest that topical retinoid monotherapy can achieve clinically significant improvements in inflammatory acne.
— id: 50164, year: 2005, vol: 27, page: 216, stat: Journal Article,

Evaluation and treatment of male and female pattern hair loss
Olsen, Elise A; Messenger, Andrew G; Shapiro, Jerry; Bergfeld, Wilma F; Hordinsky, Maria K; Roberts, Janet L; Stough, Dow; Washenik, Ken; Whiting, David A
2005 Feb;52(2):301-311, Journal of the American Academy of Dermatology
— id: 67509, year: 2005, vol: 52, page: 301, stat: Journal Article,

Etanercept does not effectively treat moderate to severe alopecia areata: an open label study
Strober, BE; Siu, K; Alexis, AF; Kim, G; Washenik, K; Sinha, A; Shupack, JL
2005 ;125(1):940-940, Journal of investigative dermatology
— id: 104636, year: 2005, vol: 125, page: 940, stat: Journal Article,

Etanercept does not effectively treat moderate to severe alopecia areata: an open-label study
Strober, Bruce E; Siu, Kimberly; Alexis, Andrew F; Kim, Gene; Washenik, Ken; Sinha, Animesh; Shupack, Jerome L
2005 Jun;52(6):1082-1084, Journal of the American Academy of Dermatology
In this prospective, open-label pilot study, we evaluated the safety and efficacy of etanercept, a TNF-alpha inhibitor, in the treatment of moderate to severe alopecia areata, alopecia totalis, or alopecia universalis. Seventeen otherwise healthy adults with moderate to severe alopecia areata were enrolled. The primary outcome measure was the extent of hair regrowth during and after the end of treatment as evaluated by the Severity of Alopecia Tool (the SALT score). After between 8 and 24 weeks of continuous treatment with etanercept 50 mg given subcutaneously twice weekly, significant regrowth of hair was not shown in any of the subjects treated. Based on these results, etanercept appears to be ineffective in treating subjects with treatment-refractory, moderate to severe alopecia areata, alopecia totalis, or alopecia universalis
— id: 56160, year: 2005, vol: 52, page: 1082, stat: Journal Article,

A systemic type I 5 alpha-reductase inhibitor is ineffective in the treatment of acne vulgaris
Leyden, J; Bergfeld, W; Drake, L; Dunlap, F; Goldman, MP; Gottlieb, AB; Heffernan, MP; Hickman, JG; Hordinsky, M; Jarrett, M; Kang, S; Lucky, A; Peck, G; Phillips, T; Rapaport, M; Roberts, J; Savin, R; Sawaya, ME; Shalita, A; Shavin, J; Shaw, JC; Stein, L; Stewart, D; Strauss, J; Swinehart, J; Swinyer, L; Thiboutot, D; Washenik, K; Weinstein, G; Whiting, D; Pappas, F; Sanchez, M; Terranella, L; Waldstreicher, J
2004 MAR ;50(3):443-447, Journal of the American Academy of Dermatology
Excessive sebum production is a central aspect of the pathophysiology of acne vulgaris. Sebaceous gland function is under androgen control and it is hypothesized that dihydrotestosterone is formed by the action of 5 alpha-reductase. Type I is the Controlling isoenzyme. This study describes a 3-month, multicenter, randomized, placebo-controlled clinical trial witha potent, selective inhibitor of type I 5 alpha-reductase used alone and in combination with systemic minocycline. Inhibition of type I 5 alpha-reductase was not associated with clinical improvement of acne when used alone and did not enhance the clinical benefit of systemic minocycline. These results indicate the need for further work at the molecular level to better understand the action of androgens on sebaceous gland function
— id: 42557, year: 2004, vol: 50, page: 443, stat: Journal Article,

Allergic contact dermatitis to topical minoxidil solution: etiology and treatment
Friedman, Edward S; Friedman, Paul M; Cohen, David E; Washenik, Ken
2002 Feb;46(2):309-312, Journal of the American Academy of Dermatology
After more than a decade of use, topical minoxidil solution has proven to be a safe and effective treatment for androgenetic alopecia. However, some patients present with complaints of pruritus and scaling of the scalp. The most common causes of these symptoms include irritant contact dermatitis, allergic contact dermatitis, or an exacerbation of seborrheic dermatitis. Patients suffering from allergic contact dermatitis may benefit from patch testing to determine the causative allergen. Among the patients we patch tested, propylene glycol was found to be the contactant in a majority of cases, not the minoxidil itself. Many of these patients may be candidates for treatment with alternative formulations using other solvents, such as butylene glycol, polysorbate, or glycerol. Although predictive, patch testing results do not ensure that the compounded preparations will be tolerated. Unfortunately, patients found to be allergic to minoxidil are no longer candidates for topical treatment of their alopecia with any preparations of minoxidil
— id: 25638, year: 2002, vol: 46, page: 309, stat: Journal Article,

Necrobiosis lipoidica diabeticorum treated with chloroquine
Nguyen, Khanh; Washenik, Ken; Shupack, Jerome
2002 Feb;46(2 Suppl Case Reports):S34-S36, Journal of the American Academy of Dermatology
Necrobiosis lipoidica diabeticorum (NLD) is an idiopathic granulomatous skin disorder. We review previously described therapies from the recent literature and report the first case of successful treatment of NLD with oral chloroquine
— id: 108422, year: 2002, vol: 46, page: S34, stat: Journal Article,

A role for leukotriene antagonists in atopic dermatitis?
Chari S; Clark-Loeser L; Shupack J; Washenik K
2001 ;2(1):1-6, American journal of clinical dermatology
Atopic dermatitis is a chronic, relapsing skin condition that affects over 2% of the population. The pathophysiology of this disease is not completely understood, but immunologic abnormalities and the subsequent release of inflammatory mediators play a central role. Treatment with glucocorticoids has long been the standard of care, but their use is limited by their adverse effect profile. Leukotrienes (LTB4, LTC4, LTD4, and LTE4) are metabolites of arachidonic acid produced through the 5-lipoxygenase pathway. They play an important role in inflammatory and atopic conditions. LT modulating agents have been used with success in asthma. Recently, there has been increased interest in the potential utility of LT antagonists in atopic dermatitis. In vitro and in vivo data have demonstrated that LTs may play a key role in atopic dermatitis. The 2 different types of LT-modulating agents are 5-lipoxygenase inhibitors and LT receptor antagonists. Since the 5-lipoxygenase inhibitor acts at an earlier step in the LT synthetic pathway, it has the ability to alter the production of all the LTs, including LTB4, while the receptor antagonists target only the cysteinyl LTs, LTC4, LTD4, and LTE4. This reduction of LTB4 activity may point to a therapeutic advantage in using LT synthesis inhibitors as opposed to LT receptor antagonists for atopic dermatitis. Clinical evidence of the use of LT agents in atopic dermatitis is limited, but initial results have been promising and these agents may one day serve as corticosteroid-sparing treatments for atopic dermatitis
— id: 26579, year: 2001, vol: 2, page: 1, stat: Journal Article,

Drug eruptions
Clark-Loeser L; Washenik K
Current dermatologic diagnosis & treatment Philadelphia : Lippincott Williams & Wilkins, 2001,
— id: 5757, year: 2001, vol: , page: 50, stat: Chapter,

Nonscarring alopecias
Clark-Loeser L; Washenik K; Reed M
Current dermatologic diagnosis & treatment Philadelphia : Lippincott Williams & Wilkins, 2001,
— id: 3728, year: 2001, vol: , page: 128, stat: Chapter,

Weight change and adverse event incidence with a low-dose oral contraceptive: two randomized, placebo-controlled trials
Coney, P; Washenik, K; Langley, RGB; DiGiovanna, JJ; Harrison, DD
2001 JUN ;63(6):297-302, Contraception
Changes in body weight and the incidence of estrogen-related side effects with low-dose oral contraceptives (OCs) containing 20 mug ethinyl estradiol (EE) have not been demonstrated in placebo-controlled trials. Two placebo-controlled, randomized trials demonstrated the efficacy of a low-dose OC for the treatment of acne in healthy females (n = 704, greater than or equal to 14 years old) with regular menstrual cycles and moderate facial acne. Patients were randomized to receive 20 mug EE/100 mug levonorgestrel (LNG) or placebo for six cycles. Body weight was measured at baseline and during Cycles 1, 3, and 6. The occurrence of adverse events was recorded at each visit. Mean changes in weight from baseline were similar with 20 mug EE/100 mug LNG [0.72 kg +/- 2.64 (SD; n = 349)] and placebo [0.56 kg +/- 2.64 (SD; n = 355; p > 0.05)] for the last measured weight of each patient. Rates of headache, nausea, weight gain, and breast pain, side effects commonly attributed to OCs, were also similar between groups (p > 0.05). No serious, unexpected, drug-related adverse events occurred during the study. The low-dose OC containing 20 mug EE/100 mug LNG is safe, well tolerated, and does not cause weight gain. (C) 2001 Elsevier Science Inc. All rights reserved
— id: 54948, year: 2001, vol: 63, page: 297, stat: Journal Article,

A randomized, controlled trial of a low-dose contraceptive containing 20 mu g of ethinyl estradiol and 100 mu g of levonorgestrel for acne treatment
Thiboutot, D; Archer, DF; Lemay, A; Washenik, K; Roberts, J; Harrison, DD
2001 SEP ;76(3):461-468, Fertility & sterility
Objective: To evaluate the efficacy of a low-dose oral contraceptive (OC) containing 100 mug of levonorgestrel (LNG) and 20 mug of ethinyl estradiol (EE) compared with placebo for the treatment of moderate acne. Design: Multicenter, randomized, double-blind, placebo-controlled clinical trial. Setting: Outpatient dermatology clinics. Patient(s): Women (greater than or equal to 14 years old; n=350) with normal menstrual cycles and moderate acne were randomized to receive LNG/EE or placebo for six cycles. Intervention(s): Twenty mug of EE and 100 mug of LNG. Main Outcome Measure(s): Acne lesion counts and clinician global assessment were performed at baseline and at each cycle. Patient self-assessment was carried out at baseline and at cycles 4 and 6; blood pressure and weight were measured at baseline and at cycles 1, 3, and 6. Result(s): Inflammatory, noninflammatory, and total lesion counts at cycle 6 with LNG/EE were significantly lower compared to placebo. Patients in the LNG/EE group also had significantly better clinician global and patient self-assessment scores than those in the placebo group at cycle. Changes in weight from baseline were similar between patients in the LNG/EE and placebo groups at all measured time points. Conclusion(s): This double-blind, placebo-controlled study demonstrates that a low-dose OC containing 20 mug of EE and 100 mug of LNG is an effective and safe treatment for moderate acne. (Fertil Steril(R) 2001;76: 461-8. (C) 2001 by American Society for Reproductive Medicine.)
— id: 54935, year: 2001, vol: 76, page: 461, stat: Journal Article,

The efficacy of a low-dose oral contraceptive for the treatment of moderate acne and its effects on biochemical markers of androgenicity: Two randomized, placebo-controlled trials
Washenik, K; Katz, H; Stanczyk, F
2001 AUG ;117(2):547-547, Journal of investigative dermatology
— id: 54911, year: 2001, vol: 117, page: 547, stat: Journal Article,

Bexarotene (Targretin (R)) capsules do not increase the number of circulating CD4+cells in patients with cutaneous T-cell lymphoma (CTCL)
Hymes, KB; Persaud, A; Inghirami, G; Yocum, R; Washenik, K
2000 NOV 16 ;96(11):240B-240B, Blood
— id: 55223, year: 2000, vol: 96, page: 240B, stat: Journal Article,

Kaposi's sarcoma
Washenik K; Clark-Loeser L; Friedman-Kien A
2000 Aug 24;343(8):581-582, New England journal of medicine
— id: 10104, year: 2000, vol: 343, page: 581, stat: Journal Article,

The leukotriene antagonist zafirlukast as a therapeutic agent for atopic dermatitis
Carucci JA; Washenik K; Weinstein A; Shupack J; Cohen DE
1998 Jul;134(7):785-786, Archives of dermatology
— id: 7525, year: 1998, vol: 134, page: 785, stat: Journal Article,

Efficacy of topical sensitizers in the treatment of alopecia areata
Rokhsar CK; Shupack JL; Vafai JJ; Washenik K
1998 Nov;39(5 Pt 1):751-761, Journal of the American Academy of Dermatology
It has been more than 2 decades since the first report of the use of dinitrochlorobenzene to induce hair growth in 2 patients with alopecia areata. Other topical sensitizers, namely squaric acid dibutylester and diphenylcyclopropenone, have been used with variable success. This article reviews the efficacy and safety of the use of topical sensitizers in the treatment of alopecia areata
— id: 10105, year: 1998, vol: 39, page: 751, stat: Journal Article,

Treatment of classic Kaposi's sarcoma with liposomal encapsulated doxorubicin
Gottlieb JJ; Washenik K; Chachoua A; Friedman-Kien A
1997 Nov 8;350(9088):1363-1364, Lancet
— id: 10106, year: 1997, vol: 350, page: 1363, stat: Journal Article,

Rediscovering mycophenolic acid: a review of its mechanism, side effects, and potential uses
Kitchin JE; Pomeranz MK; Pak G; Washenik K; Shupack JL
1997 Sep;37(3 Pt 1):445-449, Journal of the American Academy of Dermatology
Oral mycophenolic acid (MPA) therapy has been investigated in the treatment of moderate to severe psoriasis since the early 1970s and has been found to be both safe and effective. By inhibiting de novo purine biosynthesis, it functions as an antifungal, antibacterial, antiviral, and immunosuppressive agent. The recent availability of mycophenolate mofetil (MMF), a morpholinoester of MPA, has created renewed interest in the antipsoriatic properties of MPA. MMF is currently indicated for the prevention of organ rejection in transplant recipients and is used concomitantly with cyclosporine and corticosteroids. This review focuses on the pharmacology of MPA and MMF, studies of MPA in the treatment of psoriasis, and therapy with MMF. There is a potential application of MMF in the treatment of severe psoriasis and other inflammatory dermatoses, as well as topical MPA for the treatment of psoriasis
— id: 56960, year: 1997, vol: 37, page: 445, stat: Journal Article,

Anti-epiligrin cicatricial pemphigoid in a patient with HIV
Lish KM; Washenik K; Yancey KB; Yee C; Rico MJ
1997 Mar;36(3 Pt 1):486-488, Journal of the American Academy of Dermatology
— id: 10107, year: 1997, vol: 36, page: 486, stat: Journal Article,

Rediscovering thalidomide: a review of its mechanism of action, side effects, and potential uses
Tseng S; Pak G; Washenik K; Pomeranz MK; Shupack JL
1996 Dec;35(6):969-979, Journal of the American Academy of Dermatology
Thalidomide, a hypnosedative drug introduced in the 1950s, has been used in a variety of dermatologic conditions during the past few decades. Although originally withdrawn from the world market on discovery of its teratogenic effect, it has since been selectively reintroduced for use in various disorders thought to have an autoimmune or inflammatory basis. A review of the literature focused on clinical uses of thalidomide in the treatment of dermatologic diseases was performed. Diseases for which thalidomide has been found effective include erythema nodosum leprosum, prurigo nodularis, actinic prurigo, discoid lupus erythematosus, aphthous stomatitis, Behcet's syndrome, and graft-versus-host disease. Side effects such as teratogenicity and peripheral neuropathy remain its limiting factor. Thalidomide is a useful addition to the therapeutic armamentarium for treatment-resistant dermatoses as long as proper vigilance for adverse effects is maintained
— id: 56915, year: 1996, vol: 35, page: 969, stat: Journal Article,

New York University therapeutic roundtable: a panel of experts answer questions on the treatment of challenging cases
Shupack JL; Kanof N; Stolman LP; Vogel L; Whitlow M; Cohen DE; Washenik K; Lee MP; Stiller MJ
1994 Jul;54(1):29-33, Cutis
— id: 6750, year: 1994, vol: 54, page: 29, stat: Journal Article,

Identification and characterization of an abundant ovarian interstitial gland protein associated with sexual maturity in rabbits
Washenik KJ; Dunbar BS
1988 Apr;122(4):1663-1671, Endocrinology
An abundant ovarian protein with a relative mol wt (Mr) of 37K and an apparent pI of 8, associated with the onset of sexual maturity in the rabbit, has been identified. Ovaries from sexually mature (greater than 6 months old) rabbits contain large quantities of this 37K protein, while none can be detected in ovaries of immature (1 and 2 months) animals. Analysis of polyacrylamide gel electrophoresis (PAGE) gels of mature ovarian homogenates demonstrates that this protein is more abundant than actin in these preparations. It appears to be tissue specific, since it was not detected in 16 other rabbit tissues tested. Autoradiographic analysis of proteins labeled with 35S in ovarian organ culture demonstrates that a protein of identical Mr and charge to the 37K protein is synthesized in this tissue. Polyclonal sheep antiserum has been produced to the two-dimensional PAGE-purified protein. Immunoblotting of two-dimensional PAGE gels shows specific recognition of this protein and two slightly more acidic proteins of the same Mr by this antiserum. These three protein species also stain identical colors with a silver-based color stain, further suggesting that these are charge variants of the same protein. This protein is not present in corpora lutea isolated form sexually mature ovaries and is present in interstitial cell-enriched ovaries of rabbits which have been actively immunized with zona pellucida proteins. Immunocytochemical localization studies further demonstrate that this protein is localized in the interstitial gland cells. These findings suggest that this 37K protein is not associated with either follicular or luteal cells, but, rather, is linked with the 20 alpha-hydroxyprogesterone-secreting interstitial gland cell population
— id: 10108, year: 1988, vol: 122, page: 1663, stat: Journal Article,