Topical Treatment of Eczema with Triamcinolone Acetonide Benzoyl-β-Amino-Isobutyrate: A Double-Blind Comparison with Betamethasone Dipropionate

Journal of International Medical Research, May 1977

The results are reported of a double-blind study of the topical efficacy of triamcinolone acetonide benzoyl-β-amino-isobutyrate (TBI), in 21 patients with symmetrically paired lesions of acute eczema. The effects were compared with those of betamethasone dipropionate. On the indication chosen, the two corticosteroids were equally efficacious; tolerance, also, was the same for both substances.

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Topical Treatment of Eczema with Triamcinolone Acetonide Benzoyl-β-Amino-Isobutyrate: A Double-Blind Comparison with Betamethasone Dipropionate

0 F Roessei, Dermatologist, Nlcolaas Tulp Hospital , Amstelveen , The The Netherlands Netherlands The results are reported of a double-blind study of the topical efficacy of triamcinolone acetonide benzoyl- -amino-isobutyrate (TBI), in 21 patients with symmetrically paired lesions of acute eczema. The effects were compared with those of betamethasone dipropionate. On the indication chosen, the two corticosteroids were equally efficacious; tolerance, also, was the same for both substances. - Introduction The discovery of the local anti-inflammatory activity of hydrocortisone and its derivatives marked the beginning of a new era in d e r m a t o l o g y . Since, there have been continuous attempts to modify the physical and chemical properties of the hydrocortisone molecule so as to intensify the local anti i n f l a m m a t o r y e f f e c t s w h i l e r e d u c i n g absorption and diffusion through the stratum corneum and, consequently, the systemic effects. In the course of these attempts, over 100 cortisone derivatives have been synthesized; one of those with the best topical activity proved to be triamcinolone acetonide (TCA). It was found that this selectively topical action could be further intensified by esterifying TCA with amides of -aminoacids. From a series of such substances, devised by Diamanti and Eletti Bianchi (1971), triamcinolone acetonide benzoyl--amino-isobutyrate (TBI)* which is obtained by esterification of TCA in Cj, with benzoyl--amino-isobutyric acid (Figure 1), was selected as the pharmacologically most interesting substance. Pharmacological trials in animals (Troilo Ordonez 1971, Troilo Ordonez 1974) indeed demonstrated that, compared with TCA, TBI has fewer systemic effects and exerts a more intense local anti-inflammatory activity. The earliest investigations in human patients (Bertamino 1974, La Rosa, Albanese & Sposato 1974, Simoni 1974) showed that TBI could be used with good effect in inflammatory skin diseases. Proprietary name: Tibicorten Fig 1 Triamcinolone acetonide benzoyl-[i-amino-isobutyrate The purpose of the present study was an appraisal of the therapeutic efficacy of a 0-075% TBI cream by comparing its activity with that of 0 - 0 5 % b e t a m e t h a s o n e dipropionate in patients with acute eczema. Materials and Methods For this investigation we selected patients with acute forms of constitutional e c z e m a , eczematous dermatitis, etc. present with equal intensity on (parts oO both halves of the body. Prior to the start of the trial individual data concerning age, sex and earlier treatment were recorded, as well as the state of the symmetrical lesions, with a four-point scoring of the severity of the criteria, erythema, oedema, papules, vesicles, excoriations and itching: intense + + + (3), moderate (2), mild -I- (1) and absent = 0. The patients were then given two tubes marked 'left' and 'right', respectively. On the basis of a random distribution, one of the two tubes contained 0-075% TBI cream and the other contained 0-05% betamethasone dipropionate cream. Cream from the tubes marked 'left' had to be applied on the left side and from the tube marked 'right' on the right half of the body at the rate of two to three applications daily with light rubbing. If necessary, an occlusive dressing was permitted but dressings, when used at all, had to be used bilaterally. The patients were asked to return for control examination after 7 and after 14 days, at which time the intensities of the symptoms, erythema, o e d e m a , papules, v e s i c l e s , excoriations and itching were evaluated again, by means of the four-point scoring system described above. Any side-effects observed were also recorded. On completion of the trial, a global appraisal of the results was given: failure, improvement or cure, separately for the left and right body halves. Twenty-one (21) patients (10 men and 11 women) aged between 8 and 73 years (average age: 33-42 years) were included in the trial (Table 1). Constitutional (endogenous) eczema was diagnosed in 19 cases; one patient suffered from dyshidrotic eczema and one patient showed an eczematous reaction of unknown origin. The most frequent localizations were the palms of the hands and the fngers. Sixteen patients had received earlier topical treatment with a corticosteroid preparation: one patient had been treated with cod-liver oil ointment. Three patients had not had any earlier topical treatment, and in one case no data could be obtained in this respect. Tibicorten was applied twice daily in 14 and three times per day in 7 cases, always without an occlusive dressing. Out of a total of 21 applications of either preparation (Table 2), on conclusion of the investigation healing was noted 10 times on the T B I s i d e and 10 t i m e s o n t h e betamethasone dipropionate side. Clinical data regarding the individual patients constit eczema dyshidrotic eczema constit eczema consth eczema constit eczema constit eczema constit eczema constit eczema endogenous eczema constit eczema constit (numm) eczema constit eczema constit eczema constit (numm) eczema constit eczema constit eczema constit eczema (constit) eczema constit eczema constit eczema constit eczema T h e o t h e r 2 2 a p p l i c a t i o n s g a v e improvement 21 times (10 TBI and 11 betamethasone dipropionate), while failure was recorded once (TBI). In 16 cases, on completion of the trial there were no differences between the left and right sides (Table 3): eight times cure was noted and on eight occasions improvement noted. In 3 cases, the ultimate condition was better on the betamethasone dipropionate-treated side than on the TBI-treated side, while in 2 cases the TBI-treated lesions showed better Global appraisal Betamethasone dipropionate Earlier treatment hydrocortisone butyrate triamcinolone acetonide hydrocortisone butyrate hydrocortisone butyrate flumethasone pivalate betamethasone valerate flucortolone capronate none betamethasone valerate flucortolone capronate flucinolone acetonide fluomethasone pivalate betamethasone dipropionate none hydrocortisone acetate uprednidene acetate flucortolone capronate cod-liver oil ointment no data triamcinolone acetonide none Comparison of effects. Global appraisal I I C=Cure /"Improvement F-Failure improvement (cure) than those treated with betamethasone dipropionate. In 7 of the 16 cases, in which the ultimate results were globally identical, these results were achieved in different manners with the different s u b s t a n c e s , i.e. on one side improvement c.q. cure was either achieved more rapidly or was more pronounced. Talcing these specifications into account, we find that the two substances have shown completely equivalent efficacy: no difference was noted in 9 cases, Tibicorten was severe 3-\ considered to be superior to betamethasone dipropionate in 6 cases and betamethasone dipropionate was considered to be superior to TBI in 6 cases also. As regards the different effects on separate symptoms, we found that for all symptoms combined (Figure 2) betamethasone was some what more rapidly active, whereas the ultimate results after 14 days' treatment were better in the case of TBI. W h e r e a s v e s i c l e s and e x c o r i a t i o n s responded slightly better to betamethasone dipropionate (Figure 3), the papules, rhagades and keratoses showed better improvement with TBI treatment. Erythema initially responded more rapidly to betamethasone dipropionate, but the ultimate effects of both preparations on erythema were precisely the same. The symptom of itching, finally, was influenced to the same degree by the two corticosteroids. Side-effects were observed in only 2 cases: one patient (234) showed teleangiectasis on the TBI-treated side, while one other (247) showed signs of atrophy on the betamethasone side. Signs of irritation or local sensations of burning were never observed. betamethasone dipropionate mild 1 A ^o^n 0.969 v e s i c l e s r h a g a d e s E r y t h e m a P a p u l e s excoriation J L I itching Discussion and Conclusion Triamcinolone acetonide esterified b e n z o y l - - a m i n o - i s o b u t y r i c Tibicorten) was found to be an efficacious topical corticosteroid, quite suitable for the everyday practice of topical treatment of skin l e s i o n s , r e s u l t i n g constitutional or allergic eczema. Its activity proved to be globally equivalent to that of betamethasone dipropionate when the two substances were applied separately and simultaneously to symmetrical lesions of equal severity. TBI may have exerted a slightly less pronounced local anti-inflammatory effect, but it brought about faster keratolysis than betamethasone dipropionate. The effects of the two substances on itching were the same. Both TBI and betamethasone dipropionate well tolerated locally and caused no irritation nor sensations of burning. Acknowledgements T i b i c o r t e n b e t a m e t h a s o n e dipropionate samples used in this study were supplied by Dr G Vanden Bussche of Labaz (1974) Studio in doppid cieco di un nuovo frmaco corticosteroideo per uso tpico: TBI. Rassegna di Dermatologa e di Sifilografia 26,1 Troilo Ordonez (1971) Pharmacological properties of a new corticosteroid derivative: benzoyl-i-amino-isobutyrate of triamcinolone acetonie. Arzneimittel-Forschung 21,248 Troilo Ordonez (1974) Pharmacologic and toxicologic properties of a new topically active anti-inflammatory steroid. Arzneimittel-Forschung 24,2015


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F E Roessei. Topical Treatment of Eczema with Triamcinolone Acetonide Benzoyl-β-Amino-Isobutyrate: A Double-Blind Comparison with Betamethasone Dipropionate, Journal of International Medical Research, 1977, 207-212, DOI: 10.1177/030006057700500311