(Bay B 5097) Cream on Skin Candidiasis

THE KURUME MEDICAL JOURNAL Vol. 19, No. 4, 1972

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, 1972)

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 impres- sive results in the patients treated. It is a definite advantage of Bay b 5097 thatits anti-mycotic spectrum is broader than that of other conven- tional 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 candi- type), especially related to cell mediated diasis has recently increased in in- immunity, and also in adult C. M. C, as- stance and in most cases the lesion sociated with thymoma and myasthenia occupy neck, axilla and genitocrural gravis occur. Laboratory studies reve- region. aled primary defective delayed hyper- The disease is chiefly due to candida sensitivity. Thymoma induced defects albicans (C. alb.) which inhabit as a in cell mediated immunity may be the commensal the human skin, mouth, principal reasons for development of throat, gastrointestinal duct and vagina C. M. C. in adult. In the instances, vis- without causing disease. Mild candi- ceral involvment of the organisms usu- diasis, thrush and vaginal thrush, occurs ally do not occur. frequently in those f avourate sites. Antimycotic substances presently Localized skin candidiasis is often available for systemic administration induced with optimal conditions (heat, are Griseofulvin against trichophytia sweating, merceration with frequent and potassium iodide against sporotri- immersion in water) and topical appli- chosis and Amphotericin B. Amphote- cation of corticosteroids or antibiotics. ricin B possesses a broad spectrum of Chronic mucocutaneous candidiasis antimycotic activity and has shown good (C. M. C.), prolonged C. alb. infections results in the treatment of various of mucous membrane, nail, faces, scalp types of deep-seated mycosis, but has and perioral region, is common in the disadvantage of severe side effects debilitated infancy with general depres- including chill and fever following injec - sion of host defence and in the immuno- tion and impairing kidney functions. pathological disease. The lymphopenic It requires, therefore, muchcare in its form of a gammaglobulinem ia (Swiss clinical application.

259 260NAKAMA

Farbenf abriken Bayer, West-Ger- stantially improved that a negative many recently developed a tritylimida- culture could be expected by continuing zole derivative (Clotrimazole, Bay b 5097, treatment. synthetic). Insoluble in water, it is Bay b 5097 was evaluated "fair" when readily soluble in fatty solvents. Bay b either the skin lesion improved or sub- 5097 was found effective against various jective symptoms disappeared during types of mycotic diseases in its topical treatment of not less than one month, presentations. Tablets for oral therapy but positive cultures were still found. are also available. With its wide anti- The drug was judged "poor" when fungal spectrum Bayb 5097 is expected no improvement at all in mycological to be of value in a great variety of tests or symptoms were observed even mycotic infections. after more than one month's therapy.

MATERIAL AND METHODS CLINICAL RESULTS

We had the opportunity to investi- The clinical conditions and course gate clinically the efficacy of Bay b for each patient are shown in Table 1 5097 cream (1 %) in skincandidiasis in (attached), listing a total of 30 cases outpatients of the Department of Der- of skin candidiasis. matology of Kurume University Medical Efficacy-ratio in different diseases School and of the Dermatology Depart- is presented in Table 2 : the effective ment of St. Maria's Hospital in Kurume rate for skin candidiasis being 100%. city. We found the drug excellent in In no case Bay b 5097 was found to its clinical effect, with little side be ineffective. In some cases, however, effects. Our clinical results are pre- the clinical effectiveness of the drug sented inthis paper. seemed to be substantially influenced Administration and criteria of jud- by the patient's cooperation (following instructions, applying protective band- ging effectiveness of Bay b 5097 ages against interdigital candidiasis of Treated with Bay b 5097 drug were hands). cutaneous candidiasis (erythema myco- ticum infantile, pustular and papular ANALYSIS OF THERAPEUTIC type of skin candidiasis., localized skin RESULTS candidiasis, candida intertrigo, inter - digital candidiasis), and onychia et pa- Cutaneous candidiasis : 30 patients ronychia. Most of our cases of infantile mycotic Bay b 5097 cream was applied 3 times erythema and pustular type of skin daily, as a rule, or at least 2 times candidiasis were seen in the premature daily. infants center of St. Maria's Hospital, Effectiveness was judged and graded Kurumecity. In four cases, the lesions as follows : "Excellent" the symptoms were limited to face, temporal region disappeared and culturesbecame nega- and extremities. It startedas pustules tive by 15 days after onset of treatment, followed by desquamation and erosion, "Good" when negative cultures were with practically no erythema present. found after 15 days from onset of Thus, the clinical picture was somewhat treatment, or when, if it took one different from other types of skin month or more for cultures to become candidiasis. The cases responded well nagative, the skin lesions were so sub- to appropriate therapy, and healed TABLE 1 Results o use o Bay b 5097 cream (1%) against skin candidiasis 262NAKAMA

TABLE 2 Results of use of Bay b 5097 cream (1%) against skin candidiasis

Fig. 1 Fig. 2

Fig. 1 and Fig. 2 Erythema micoticum infantile. Fig. 3 Papular type of skin candidiasis.

Each case has almost healded after 7 days topical use of Bay b 5097 cream.

Fig. 3 A NEW ANTIMYCOTIC SUBSTANCE "BAY B 5097"263 completely in 3 to 5 days. These cases Ichthammol zinc oil. The infants were are differentiated from others as "pus- all premature, born one to two months tular type of skin candidiasis". The before term. Infantilemycotic erythe- development of papules, pustules and ma responded less rapidly to treatment desquamation in infants and adult ma- than pustular type of skin candidiasis les' forehead, face, and trunk is termed requiring 15 to 20 days for a complete as "localized skin candidiasis" in the healing. Even when mycologically nega- narrower sense. tive, erythema persisted in many cases. Quickest to heal was pustular type This was remedied rather quickly when of skin candidiasis. 1 % Ichtahmmol 1 % Ichthammol zinc oil or corticosteroid zinc oil used before Bay b5097 had ointment was administered concomi- failed to improve the conditions, which tantly. Candia intertrigo was found in were quickly cured after Bay b 5097 3 adults and responded well to treatment "excellent" in 2 patients cream was applied. , good in 1 case. In 10 cases of infantile mycotic erythema, the lesions were extensively REFERENCES involving neck, trunk, and genitocrural 1) PLEMPEL, M. et al : Deut. Med. Wschr. 94, region. The cases had been refractory 1, 1969. to treatment with Pyoktanin and 1 %