Clinical and Mycological Evaluation of Therapeutic Effectiveness of Solanum chrysotrichum Standardized Extract on Patients with Pityriasis capitis (Dandruff). A Double Blind and Randomized Clinical Trial Controlled with Ketoconazole

Abstract

Dandruff (also called Pityriasis capitis) is a seborrhoeic dermatitis of the scalp. It has been correlated with the pathological colonization of the scalp with yeast from the genus Malassezia; this illness has a worldwide distribution and represents 25 % of all scalp dermatosis cases. It has been demonstrated that the extract obtained from leaves of the plant Solanum chrysotrichum possesses biological activity against dermatophytes and yeast. Different steroidal saponins with antimycotic activity have been isolated from the active extract. Clinical trials with standardized extracts prepared with this vegetal species report high rates of clinical and mycological effectiveness in the treatment of Tinea pedis, without producing secondary effects. The aim of this randomized, double blind and controlled clinical study, was to compare the therapeutic effectiveness and tolerability of a shampoo containing a standardized extract of S. chrysotrichum (applied every third day, for 4 weeks), against 2 % ketoconazole in the topical treatment of Pityriasis capitis. From a total of 120 patients with the clinical diagnosis of Pityriasis capitis, 14 subjects were eliminated because the presence of Malassezia was not proved, another two patients withdrew from the study due to non-medical causes and one more withdrew because Tinea capitis was diagnosed. Therefore, the final analysis included 51 subjects in the experimental group and 52 in the control; in 45.6 % of the cases M. furfur was identified as the pathogenic agent, in 44.66 % M. globosa was isolated, and 9.71 % of the patients had a mixed infestation. At the end of the treatment period, the prepared phytopharmaceutical with the standardized extract from S. chrysotrichum achieved a clinical effectiveness (total absence of signs and symptoms produced by Pityriasis capitis) of 92.16 %; the mycological effectiveness (absence of Malassezia spp. in the direct examination and culture) was 68.63 %; whilst the tolerability (absence of side effects that prompt subjects to abandon the treatment) was 100 %. The therapeutic success (clinical and mycological effectiveness plus tolerability) was 64.71 %. The comparison of these results with that obtained from the group treated with 2 % ketoconazole, showed no significant differences (χ², p > 0.23). These results show the therapeutic effectiveness and tolerability of the standardized extract from S. chrysotrichum on the local treatment of Pityriasis capitis associated with the yeast of the genus Malassezia.

Solanum chrysotrichum - Solanaceae - Malassezia - Pityriasis capitis - Ketoconazole - Dandruff - complementary and alternative medicine

References

• 1 Saint-Leger D. The history of dandruff and dandruff in history. A homage to Raymond Sabouraud.  Ann Dermatol Venereol. 1990;  117 23-7
• 2 Fitz-Patrich E. Dermatología en Medicina Familiar 3a. Ed. Editorial Panamericana México; 1995: 380-2
• 3 Inanir I, Sahin M T, Gunduz K, Dinc G, Turel A, Ozturkcan S. Prevalence of skin conditions in primary school children in Turkey: differences based on socioeconomic factors.  Pediatr Dermatol. 2002;  19 307-11
• 4 Harding C R, Moore A E, Rogers J S, Meldrum H, Scott A E, McGlone F P. Dandruff: a condition characterized by decreased levels of intercellular lipids in scalp stratum corneum and impaired barrier function.  Arch Dermatol Res. 2002;  294 221-30
• 5 Schmidt A. Malassezia furfur: a fungus belonging to the physiological skin flora and its relevance in skin disorders.  Cutis. 1997;  59 21-4
• 6 Rodero L, Boutureira M, Demkura H, Burkett A, Fernandez C, Losso M, Jauregui-Rueda H, Monticelli A, Vitale R, Canteros C, Hochenfellner F, Vivot W, Davel G. Yeast infections: causative agents and their antifungal resistance in hospitalized pediatric patients and HIV-positive adults.  Rev Argent Microbiol. 1997;  29 7-15
• 7 Lozoya X, Aguilar A. Encuesta sobre el uso actual de plantas en la medicina tradicional Mexicana.  Rev Med IMSS. 1987;  25 283-91
• 8 Lozoya X, Navarro V, García M, Zurita M. Solanum chrysotrichum (Schldl.) a plant used in Mexico for the treatment of skin mycoses.  J Ethnopharmacol. 1991;  36 127-32
• 9 Herrera-Arellano A, Rodríguez-Soberanes A, Martínez-Rivera MA; Martínez-Cruz E, Zamilpa A, Alvarez L, Tortoriello J. Effectiveness and tolerability of a standardized phytodrug derived from Solanum chrysotrichum on tinea pedis. A controlled and randomized clinical trial.  Planta Med. 2003;  69 390-5
• 10 Alvarez L, Pérez M C, González J L, Navarro V, Villareal M L, Olson J O. SC-1 an antimycotic spirostan saponin from S. chrysotrichum .  Planta Med. 2001;  67 372-4
• 11 Zamilpa A, Tortoriello J, Navarro V, Delgado G, Alvarez L. Five new steroidal saponins from S. chrysotrichum leaves and their antimycotic activity.  J Nat Prod. 2002;  65 1815-19
• 12 Conti Diaz I A, Civila E, Veiga R. The importance of microscopic examination in the management of desquamative diseases of the scalp.  Mycopathologia.. 2002;  153 71-5
• 13 Nakabayashi A, Sei Y, Guillot J. Identification of Malassezia species isolated from patients with seborrhoeic dermatitis, atopic dermatitis, pityriasis versicolor and normal subjects.  Med Mycol. 2000;  38 337-41
• 14 Arrese J E, Piérard-Franchimont C, De Doncker P, Heremans A, Cauwenbergh G, Piérard G E. Effect of ketoconazole-medicated shampoos on squamometry and Malassezia ovalis load in Pityriasis capitis .  Cutis. 1996;  58 235-7
• 15 Squire R A, Goode K. A randomized, single-blind, single-centre clinical trial to evaluate comparative clinical efficacy of shampoos containing ciclopirox olamine (1.5 %) and salicylic acid (3 %), or ketoconazole (2 %, Nizoral) for the treatment of dandruff/seborrhoeic dermatitis.  J Dermatolog Treat. 2002;  13 51-60
• 16 Van Cutsem J, Van Gerven F, Fransen J, Schrooten P, Janssen P AJ. The in vitro antifungal activity of ketoconazole, zinc pyrithione, and selenium sulphide against pityrosporosis and their efficacy as a shampoo in the treatment of experimental Pityrosporum in guinea pigs.  J Am Acad Dermatol. 1990;  2 933-8
• 17 Pierard-Franchimont C, Goffin V, Decroix J, Pierard G E. A multicenter randomized trial of ketoconazole 2 % and zinc pyrithione 1 % shampoos in severe dandruff and seborrheic dermatitis.  Skin Pharmacol Appl Skin Physiol. 2002;  15 434-41
• 18 Maddin W S, Margesson L J, Rosenthal D. A randomized, double-blind trial of ketoconazole 2 % shampoo versus selenium sulfide 2.5 % shampoo in the treatment of moderate to severe dandruff.  J Am Acad Dermatol. 1993;  29 1008-12
• 19 Yoshimura T, Kudoh K, Aiba S, Tagami H. Anti-inflammatory effects of ketoconazole for the inflammation induced on the skin of hairless guinea-pigs by repeated applications of heat-killed spores of M. furfur: A comparative study with hydrocortisone 17-butyrate.  J Dermatol Treat. 1995;  6 113-6
• 20 Satchell A C, Saurajen A, Bell C, Barnetson R S. Satchell AC, Saurajen A, Bell C, Barnetson RS. Treatment of dandruff with 5 % tea tree oil shampoo.  J Am Acad Dermatol. 2002;  47 852-5
• 21 Kwon-Chung K J, Bennett J E. Medical mycology. Lea and Febiger Philadelphia; 1992: pp 81-102
• 22 Van Gerven F, Odds F C. The anti-Malassezia furfur activity in vitro and in experimental dermatitis of six imidazole antifungal agents: bifonazole, clotrimazole, flutrimazole, ketoconazole, miconazole and sertaconazole Mycoses. 1995 38: 389-93