Prospective, Open-Label, Multi-Centre, Randomized Study to Compare the Effectiveness, Safety, and Tolerability of Lulican™ Shampoo Versus Ketoconazole Shampoo in Indian Adult Patients With Mild to Moderate Scalp Seborrheic Dermatitis (LEAD Study)

Introduction Although seborrheic dermatitis (SD) is not lethal, it has a significant impact on the quality of life. Many cases of SD are managed with ketoconazole, but luliconazole has shown an equivalent or lower minimum inhibitory concentration (MIC), but not many studies have been done for its efficacy and safety in SD. With this in mind, we set out to conduct a study comparing the effectiveness, safety, and tolerability of Lulican™ (luliconazole 1% + salicylic acid 3% + ZPTO 1%) shampoo and Ketoconazole (Ketoconazole 2% + ZPTO 1%) shampoo in the treatment of SD. Materials and methods In this prospective, randomized, multi-center study, mild to moderate scalp SD patients were prescribed Lulican™ or Ketoconazole shampoo three times a week for a duration of four weeks. Effectiveness assessment was done with the Seborrheic-Dermatitis-Severity-Score (SDSS) and Physician-Global-Assessment (PGA), and quality of life was assessed with the help of the Scalpdex-23 questionnaire. Results At four weeks, 68% and 57.9% reduction was seen in SDSS in Lulican™ and Ketoconazole shampoo, respectively. Moreover, 58% and 44% of patients achieved excellent to moderate responses as per PGA with Lulican™ and ketoconazole shampoo, respectively. For safety, no statistical difference was reported, but product tolerability and subjective cosmetic acceptability were significantly better in the Lulican™ group as compared to the Ketoconazole group at the end of four weeks. The mean Scalpdex-23 score at week four was reduced by 35.7% and 21.1% in Lulican™ and ketoconazole groups, respectively (p<0.05). Conclusion While both treatments were successful in alleviating SD symptoms and were well tolerated, Lulican™ stood out as a preferred treatment option due to better quality of life (QoL) improvement in SD.

[1]  Chuanjian Lu,et al.  Clinical characteristics and quality of life in seborrheic dermatitis patients: a cross-sectional study in China , 2020, Health and Quality of Life Outcomes.

[2]  Shadi Damanpour,et al.  Ketoconazole shampoo-induced hair discoloration, , 2019, International journal of women's dermatology.

[3]  E. Salah,et al.  Trichogenic effect of topical ketoconazole versus minoxidil 2% in female pattern hair loss: a clinical and trichoscopic evaluation , 2019, Biomedical Dermatology.

[4]  Anton C. de Groot.  Ketoconazole , 2018, Reactions Weekly.

[5]  A. Tavakkoli,et al.  The myrtus communis L. solution versus ketoconazole shampoo in treatment of dandruff: A double blinded randomized clinical trial. , 2018, JPMA. The Journal of the Pakistan Medical Association.

[6]  C. Yeung,et al.  Treatment of Seborrhoeic Dermatitis in Asia: A Consensus Guide , 2016, Skin Appendage Disorders.

[7]  S. Jiamton,et al.  Clinical Characteristics and Quality of Life of Seborrheic Dermatitis Patients in a Tropical Country , 2015, Indian journal of dermatology.

[8]  D. Khanna,et al.  Luliconazole for the treatment of fungal infections: an evidence-based review , 2014, Core evidence.

[9]  M. Kaur,et al.  A randomized, multicenter, double-blind, vehicle-controlled study evaluating the efficacy and safety of luliconazole cream 1% once daily for 7 days in patients aged ≥ 12 years with tinea cruris. , 2014, Journal of drugs in dermatology : JDD.

[10]  A. Katsambas,et al.  Seborrheic dermatitis: etiology, risk factors, and treatments: facts and controversies. , 2013, Clinics in dermatology.

[11]  Goldenberg Gary.  Optimizing treatment approaches in seborrheic dermatitis. , 2013, The Journal of clinical and aesthetic dermatology.

[12]  S. Ranganathan,et al.  A New Postulate on Two Stages of Dandruff: A Clinical Perspective , 2011, International journal of trichology.

[13]  I. Stefanaki,et al.  Therapeutic update on seborrheic dermatitis. , 2010, Skin therapy letter.

[14]  D. Gangopadhyay,et al.  SEASONAL VARIATION IN PEDIATRIC DERMATOSES , 2010, Indian journal of dermatology.

[15]  J. Szepietowski,et al.  Quality of life in patients suffering from seborrheic dermatitis: influence of age, gender and education level , 2009, Mycoses.

[16]  A. Singal.  Butenafine and superficial mycoses: current status , 2008, Expert opinion on drug metabolism & toxicology.

[17]  T. Sugita,et al.  Molecular analysis of Malassezia microflora in seborrheic dermatitis patients: comparison with other diseases and healthy subjects. , 2008, The Journal of investigative dermatology.

[18]  J. Peyrí,et al.  Perfil clínico, terapéutico y calidad de vida de los pacientes con dermatitis seborreica , 2007 .

[19]  T. Nishikawa,et al.  Dose‐finding comparative study of 2 weeks of luliconazole cream treatment for tinea pedis – comparison between three groups (1%, 0.5%, 0.1%) by a multi‐center randomised double‐blind study , 2007, Mycoses.

[20]  R. Ratnavel,et al.  Clinical efficacies of shampoos containing ciclopirox olamine (1.5%) and ketoconazole (2.0%) in the treatment of seborrhoeic dermatitis , 2007, The Journal of dermatological treatment.

[21]  J. Peyri,et al.  [Clinical and therapeutic profile and quality of life of patients with seborrheic dermatitis]. , 2007, Actas dermo-sifiliograficas.

[22]  T. Nishikawa,et al.  A comparative clinical study between 2 weeks of luliconazole 1% cream treatment and 4 weeks of bifonazole 1% cream treatment for tinea pedis , 2006, Mycoses.

[23]  T. Sugita,et al.  Antifungal Activities of Tacrolimus and Azole Agents against the Eleven Currently Accepted Malassezia Species , 2005, Journal of Clinical Microbiology.

[24]  E. Çalıkoğlu,et al.  Psychiatric tests in seborrhoeic dermatitis. , 2005, Acta dermato-venereologica.

[25]  L. Misery,et al.  [Treatment for seborrheic dermatitis]. , 2004, Annales de dermatologie et de venereologie.

[26]  H. Yamaguchi,et al.  In vitro activity of novel imidazole antifungal agent NND-502 against Malassezia species. , 2003, International journal of antimicrobial agents.

[27]  E. Evans,et al.  Immunology of Diseases Associated with Malassezia Species , 2002, Clinical Microbiology Reviews.

[28]  J. Arrese,et al.  Effect of Ketoconazole 1% and 2% Shampoos on Severe Dandruff and Seborrhoeic Dermatitis: Clinical, Squamometric and Mycological Assessments , 2001, Dermatology.

[29]  P. Kerkhof,et al.  Psoriasis of the Scalp , 2001 .

[30]  P. C. van de Kerkhof,et al.  Psoriasis of the scalp. Diagnosis and management. , 2001, American journal of clinical dermatology.

[31]  U. Richarz-Barthauer,et al.  Successful treatment and prophylaxis of scalp seborrhoeic dermatitis and dandruff with 2% ketoconazole shampoo: results of a multicentre, double‐blind, placebo‐controlled trial , 1995, The British journal of dermatology.