A CLINICAL INVESTIGATION OF CLOTRIMAZOLE (BAY B 5097) CREAM ON SKIN CANDIDIASIS

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1 THE KURUME MEDICAL JOURNAL Vol. 19, No. 4, 197 A CLINICAL INVESTIGATION OF CLOTRIMAZOLE (BAY B 5097) CREAM ON SKIN CANDIDIASIS TAKEO NAKAMA Department of Dermatology, Kurume University School of Medicine, Kurume, Japan (Received for Publication December 5, 197) An open, controlled, clinical investigation of a new antimycotic substance, Clotrimazole (Bay b 5097), comprising 30 patients with candidiasis confirmed the reliable therapeutic efficacy of the substance in the presentation of 1% cream. The excellent anti-fungal efficacy of the substance yielded impressive results in the patients treated. It is a definite advantage of Bay b 5097 thatits anti-mycotic spectrum is broader than that of other conventional topical agents. Side effects were described as erythema (1 time), not severe and not necessitating interruption or cessation of therapy. It has been noticed that skin candidiasis has recently increased in instance and in most cases the lesion occupy neck, axilla and genitocrural region. The disease is chiefly due to candida albicans (C. alb.) which inhabit as a commensal the human skin, mouth, throat, gastrointestinal duct and vagina without causing disease. Mild candidiasis, thrush and vaginal thrush, occurs frequently in those f avourate sites. Localized skin candidiasis is often induced with optimal conditions (heat, sweating, merceration with frequent immersion in water) and topical application of corticosteroids or antibiotics. Chronic mucocutaneous candidiasis (C. M. C.), prolonged C. alb. infections of mucous membrane, nail, faces, scalp and perioral region, is common in debilitated infancy with general depression of host defence and in the immunopathological disease. The lymphopenic form of a gammaglobulinem ia (Swiss type), especially related to cell mediated immunity, and also in adult C. M. C, associated with thymoma and myasthenia gravis occur. Laboratory studies revealed primary defective delayed hypersensitivity. Thymoma induced defects in cell mediated immunity may be the principal reasons for development of C. M. C. in adult. In the instances, visceral involvment of the organisms usually do not occur. Antimycotic substances presently available for systemic administration are Griseofulvin against trichophytia and potassium iodide against sporotrichosis and Amphotericin B. Amphotericin B possesses a broad spectrum of antimycotic activity and has shown good results in the treatment of various types of deep-seated mycosis, but has the disadvantage of severe side effects including chill and fever following injec - tion and impairing kidney functions. It requires, therefore, muchcare in its clinical application. 59

2 60NAKAMA Farbenf abriken Bayer, West-Germany recently developed a tritylimidazole derivative (Clotrimazole, Bay b 5097, synthetic). Insoluble in water, it is readily soluble in fatty solvents. Bay b 5097 was found effective against various types of mycotic diseases in its topical presentations. Tablets for oral therapy are also available. With its wide antifungal spectrum Bayb 5097 is expected to be of value in a great variety of mycotic infections. MATERIAL AND METHODS We had the opportunity to investigate clinically the efficacy of Bay b 5097 cream (1 %) in skincandidiasis in outpatients of the Department of Dermatology of Kurume University Medical School and of the Dermatology Department of St. Maria's Hospital in Kurume city. We found the drug excellent in its clinical effect, with little side effects. Our clinical results are presented inthis paper. Administration and criteria of judging effectiveness of Bay b 5097 Treated with Bay b 5097 drug were cutaneous candidiasis (erythema mycoticum infantile, pustular and papular type of skin candidiasis., localized skin candidiasis, candida intertrigo, inter - digital candidiasis), and onychia et paronychia. Bay b 5097 cream was applied 3 times daily, as a rule, or at least times daily. Effectiveness was judged and graded as follows : "Excellent" the symptoms disappeared and culturesbecame negative by 15 days after onset of treatment, "Good" when negative cultures were found after 15 days from onset of treatment, or when, if it took one month or more for cultures to become nagative, the skin lesions were so substantially improved that a negative culture could be expected by continuing treatment. Bay b 5097 was evaluated "fair" when either the skin lesion improved or subjective symptoms disappeared during treatment of not less than one month, but positive cultures were still found. The drug was judged "poor" when no improvement at all in mycological tests or symptoms were observed even after more than one month's therapy. CLINICAL RESULTS The clinical conditions and course for each patient are shown in Table 1 (attached), listing a total of 30 cases of skin candidiasis. Efficacy-ratio in different diseases is presented in Table : the effective rate for skin candidiasis being 100%. In no case Bay b 5097 was found to be ineffective. In some cases, however, the clinical effectiveness of the drug seemed to be substantially influenced by the patient's cooperation (following instructions, applying protective bandages against interdigital candidiasis of hands). ANALYSIS RESULTS OF THERAPEUTIC Cutaneous candidiasis : 30 patients Most of our cases of infantile mycotic erythema and pustular type of skin candidiasis were seen in the premature infants center of St. Maria's Hospital, Kurumecity. In four cases, the lesions were limited to face, temporal region and extremities. It startedas pustules followed by desquamation and erosion, with practically no erythema present. Thus, the clinical picture was somewhat different from other types of skin candidiasis. The cases responded well to appropriate therapy, and healed

3 TABLE 1 Results o use o Bay b 5097 cream (1%) against skin candidiasis

4 6NAKAMA Results of use of Bay TABLE b 5097 cream (1%) against skin candidiasis 1 1 and 3 Papular Erythema infantile. type of skin Each case has 7 days topical cream. 3 micoticum candidiasis. almost healded after use of Bay b 5097

5 A NEW ANTIMYCOTIC SUBSTANCE "BAY B 5097"63 completely in 3 to 5 days. These cases are differentiated from others as "pustular type of skin candidiasis". The development of papules, pustules and desquamation in infants and adult males' forehead, face, and trunk is termed as "localized skin candidiasis" in the narrower sense. Quickest to heal was pustular type of skin candidiasis. 1 % Ichtahmmol zinc oil used before Bay b5097 had failed to improve the conditions, which were quickly cured after Bay b 5097 cream was applied. In 10 cases of infantile mycotic erythema, the lesions were extensively involving neck, trunk, and genitocrural region. The cases had been refractory to treatment with Pyoktanin and 1 % Ichthammol zinc oil. The infants were all premature, born one to two months before term. Infantilemycotic erythema responded less rapidly to treatment than pustular type of skin candidiasis requiring 15 to 0 days for a complete healing. Even when mycologically negative, erythema persisted in many cases. This was remedied rather quickly when 1 % Ichthammol zinc oil or corticosteroid ointment was administered concomitantly. Candia intertrigo was found in 3 adults and responded well to treatment "excellent" in patients, good in 1 case. REFERENCES 1) PLEMPEL, M. et al : Deut. Med. Wschr. 94, 1, 1969.