Authors: Therese Giannine V. Ledesma, MD, DPDS , Eleanor G. Casal-Panis, MD, DPDS Leilani R. Senador, MD, FPDS, Johannes F. Dayrit, MD, FPDS, Ma. Teresita G. Gabriel, MD, FPDS

Abstract

Background: Lichen simplex chronicus (LSC) is a chronic, pruritic, inflammatory skin condition that causes thickening of affected skin areas due to persistent scratching. It is currently managed by clobetasol propionate 0.05% ointment, but inherent side effects and high cost limit its use. Bee propolis is known to possess anti-inflammatory activity, rendering it as a potential alternative treatment for LSC.

Objective: To compare the safety and efficacy of bee propolis 5% ointment with clobetasol propionate 0.05% ointment in the treatment of LSC.

Methods: This was a randomized, double-blind clinical trial. The first phase was a patch test of bee propolis 5% ointment on 30 healthy volunteers. The second phase was a clinical trial of 80 patients diagnosed with LSC (aged 18-60 years), randomly assigned to receive either bee propolis 5% ointment or clobetasol propionate 0.05% ointment for two weeks. Outcome measures were determined based on the intensity of pruritus measured by Visual Analog Scale (VAS), interference in daily activities measured by Activities of Daily Living (ADL), appearance of lesion measured by photographic assessment and lesion size. Adverse events were recorded and statistical analysis was done.

Results: The test ointment, bee propolis 5% ointment was classified as non-irritant and safe for clinical trial. Seventy-three out of 80 patients (91.25%) completed the trial. There were no significant differences in the mean VAS score (p = 0.86, 0.47, 0.14), mean ADL score (p = 0.68, 0.66, 0.31), mean PA score (p = 1.0, 0.52, 1.0) and mean lesion size (p = 0.595, 0.15, 0.05) between the two treatment groups from the baseline to day 7 and day 14. There was one adverse event of mild stinging sensation in the bee propolis group after one week of treatment, but no statistically significant adverse events (p = 0.5) were noted in both treatment groups.

Conclusion: Bee propolis 5% ointment was equally safe and effective as clobetasol propionate 0.05% ointment in decreasing pruritus, improving activities of daily living, resolving lesions and decreasing lesion size in patients with LSC. It is therefore a good alternative to clobetasol propionate 0.05% ointment in the treatment of LSC.

Citation

Ledesma, TG, Casal-Panis, EG, Senador, L, Dayrit, F. & Gabriel, MT (2017). A randomized, double-blind, controlled trial on the safety and efficacy of bee propolis 5% ointment versus clobetasol propionate 0.05% ointment for lichen simplex chronicus. Journal of the Philippine Dermatological Society, 26(2), 30-35.

Keywords

Lichen simplex chronicus, bee propolis, clobetasol propionate

1. Danto, JL. Incidence of Lichen Simplex Chronicus in Orientals and Caucasians.
   Canadian Medical Associafion Journal. 1956 Dec; 75:1029-1031.
2. Elmariah SB, Lerner EA. Topical Therapies for Pruritus. Semin Cutan Med Surg.
   2011; 30:118-126.
3. Miller JA, Munro DD. Topical corticosteroids: clinical pharmacology and therapeutic
   use. Drugs. 1980 Feb; 19(2):119-34.
4. Baumann L, Kerdel F. Topical Glucocorticoids. In: Freedberg IM, Eisen AZ, Wolff K, et al. Eds. Fitzpatrick’s Dermatology in General Medicine. Ed 5. New York: McGraw- Hill,
5. Bankova V, de Castro S, Marcucci M. Propolis: recent advances in chemistry and
   plant origin. Apidologie. 2000; 31:3-15.
6.  Bankova V. Chemical diversity of propolis and the problem of standardization. J of
   Ethno Pharmacology. 2005; 100:114-117.
7. Borrelli, F, Maffia P, Pinto L, Ianaro A, Russo A, Capasso F, Ialenti A. Phytochemical compounds involved in the anti-inflammatory effect of propolis extract. Fitoterapia. 2002; 73(1)S53-S63.
8.  Castaldo S, Capasso F. Propolis, an old remedy used in modern medicine. Fitoterapia
   73 2002; Suppl. 1:S1-S6.
9.  Khachaturov AA, Gudkov AI. Propolist therapy of certain dermatoses and burns in
   the far north. Vestn Dermatol Venerol. 1969; 43:63-5.
10. Walgrave SE, Warshaw EM, Glesne LA. Allergic Contact Dermatitis from Propolis.
    Dermatitis. 2005; 16(4):209-215.
11. Silici S, Kutluca S. Chemical composition and antibacterial activity of propolis collecte by three different races of honeybees in the same region. J Ethnopharmacol. 2005; 99(1):69-73.
12. Wahlberg J E. Patch testing. In Textbook of Contact Dermatitis, 3rd edition, RycroftR J G, Menne T, Frosch P J, Lepoittevin J-P (eds), Berlin, Springer-Verlag, 2001: pp. 435-468.
13. Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Research in Nursing and Health. 1990; 13:227-236.
14. Tanner LA, Reilly M, Meltzer EO, et al. Effect of Fexofenadine HCl on quality of life and work, classroom, and daily activity impairment in patients with seasonal allergic rhinitis. American Journal of Managed Care. 1999; 5(4):S235-S247.
15. Yosipovitch G, Sugeng MW, Chan YH. The effect of topically applied aspirin on localized circumscribed lichen simplex chronicus. J Am Acad Derm. 2000; 45(6-1): 910-913.
16. Patiño-Guiliano VR, Belisario MPS. Efficacy and safety of topical aspirin for persistent lichen simplex chronicus: A double blind, randomized, placebo-controlled crossover trial. J Phil Dermatol Soc. 2005; 14(1):27-32.
17.  Burgin S. Nummular Eczema and Lichen Simplex Chronicus/Prurigo Nodularis. In: Wolff K, Goldsmith L, Katz S, et al. Eds. Fitzpatrick’s Dermatology in General Medicine. Ed 7. New York: McGraw-Hill 2008:160-162.
18. Arnold HL, Odom RB, James WD. Pruritus and Neurocutaneous Dermatoses. In: Andrew’s Diseases of the Skin: Clinical Dermatology. Ed 5. Philadelphia: W. B. Saunders Company 1990; 51-67.
19. Koca R, Altin R, Konuk N, Altinyazar H.C., Levent K. Sleep disturbance in patients with lichen simplex chronicus and its relationship to nocturnal scratching: a case control study. Southern Med Journal. 2006; 99(5):482-486.
20. De Castro SL. Propolis: Biological and Pharmacological Activities. Therapeutic Uses
    of This Bee-product. Ann Rev Biomed Sci. 2001; 3:49-83.
21.  Datz B, Yawalker S. A double-blind multicenter trial of 0.05% halobetasol propionate ointment and 0.05% clobetasol 17-propionate ointment in the treatment of patients with chronic, localized atopic dermatitis or lichen simplex chronicus. J Am Acad of Dermatol. 1991; 25(6):1157-1160.
22. Tianco EAV, Teodosio GB, Alberto N. Survey of skin lesions in the Filipino elderly.
    Int J Derm. 1992; 31:196-198.
23. Hausen BM, Wollenweber E, SenffH, Post B. Propolis allergy. (I). Origin, properties,
    usage and literature review. Contact Dermafifis. 1987; 19(3):163-70.
24. Greaves MW1, Wall PD. Pathophysiology of itching. Lancet. 1996 Oct 5;
    348(9032):938-40.
    42 J Phil Dermatol Soc • November 2017 • ISSN: 2094-201X

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