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Article history: Background: Seborrheic dermatitis (SD) is a chronic dermatitis with periods of remission and relapse that
Received 5 September 2016 requires long-term treatment.
Received in revised form 28 November 2016 Objective: We compared the efcacy and safety of treatment with sertaconazole with standard corticoste-
Accepted 28 November 2016 roid medications in adults with facial SD.
Available online xxxx
Methods: In this double-blind, randomized controlled trial, 60 patients with a diagnosis of SD were enrolled.
Patients were instructed to apply either sertaconazole 2% cream (30 patients) or hydrocortisone 1% cream
(30 patients) twice daily to the affected area of the face. The severity of facial SD was assessed at 0, 2, and
4 weeks of treatment. Secondary efcacy measures included patient assessment of seborrhea, adverse
events, and improvement percentage (IP).
Results: SD lesions cleared signicantly (p b .05) and similarly in both treatment groups (p N .05). Both treat-
ments resulted in signicant improvement of SD lesions and the rate of adverse events was similar in both
groups. The IP was higher for treatment with hydrocortisone in Week 2 and similar in both groups at the end
of the study.
Limitations: Limitations include the small number of patients who were recruited for this study and the lack of
evaluation of time to relapse.
Conclusion: Treatment with topical sertaconazole may be regarded as a substitute for topical corticosteroid
medications due to the fewer adverse events and similar efcacy.
2016 The Authors. Published by Elsevier Inc. on behalf of Women's Dermatologic Society. This is an open
access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
http://dx.doi.org/10.1016/j.ijwd.2016.11.008
2352-6475/ 2016 The Authors. Published by Elsevier Inc. on behalf of Women's Dermatologic Society. This is an open access article under the CC BY-NC-ND license
(http://creativecommons.org/licenses/by-nc-nd/4.0/).
Please cite this article as: Balighi K, et al, Hydrocortisone 1% cream and sertaconazole 2% cream to treat facial seborrheic dermatitis: A double-
blind, randomized clinical trial, International Journal of Women's Dermatology (2016), http://dx.doi.org/10.1016/j.ijwd.2016.11.008
2 K. Balighi et al. / International Journal of Women's Dermatology xxx (2016) xxxxxx
Methods and materials t tests were used to compare the efcacy of the treatment groups.
Paired t tests were applied to evaluate the efcacy of each treatment
Patient selection at 2- and 4-week timepoints after treatment initiation.
Please cite this article as: Balighi K, et al, Hydrocortisone 1% cream and sertaconazole 2% cream to treat facial seborrheic dermatitis: A double-
blind, randomized clinical trial, International Journal of Women's Dermatology (2016), http://dx.doi.org/10.1016/j.ijwd.2016.11.008
K. Balighi et al. / International Journal of Women's Dermatology xxx (2016) xxxxxx 3
12
Seborrhea score
10
0
0 2 4
time(weeks)
hydrocortisone 1% sertaconazole 2%
Fig. 1. Within-group decrease in seborrhea score from baseline to study end (p b .05 for both treatment groups). There was no signicant difference between the treatment groups at
any timepoint.
ares and maintaining remission. Because no permanent cure for SD (Elewski and Cantrell, 2011; Firooz et al., 2006; Goldust et al.,
exists, long-term treatment is required in patients (Dessinioti and 2013a, 2013b; Papp et al., 2012). In a double-blind, randomized, con-
Katsambas, 2013; Gupta and Bluhm, 2004). Effective therapies that trolled study, Goldust et al. (2013a) compared the efcacy of twice
have been reported for SD include anti-inammatory agents, daily application of topical hydrocortisone 1% with that of topical
keratolytic agents, antifungal treatments, and alternative medica- sertaconazole in 69 consecutive patients in each treatment group.
tions (Bikowski, 2009; Koca et al., 2003; Naldi and Rebora, 2009; Both groups underwent 4 weeks of treatment. The majority of pa-
Schwartz et al., 2006). In this randomized, controlled trial, we com- tients had a moderate SD index in the pretreatment stage and most
pared the efcacy and safety of topical hydrocortisone 1% with topical patients showed a mild SD index in the posttreatment stage (p N
sertaconazole 2% in the treatment of facial SD. .05). Patient satisfaction was the highest among those who were
Our results showed an equal decrease in the SD severity score after treated with sertaconazole after 28 days of treatment (p b .05;
2- and 4-week timepoints of treatment between both agents (p N .05). Goldust et al., 2013a, 2013b). These results are similar to our present
The efcacy of the two topical agents was also compared with a new ndings and conrm the efcacy of topical sertaconazole in the treat-
variable called IP. On the basis of the IP, hydrocortisone 1% achieved ment of patients with facial SD.
better therapeutic results after 2 weeks of treatment; however, similar
results were obtained in both groups at Week 4 of the study. Conclu- Conclusions
sively, the treatment of SD by topical hydrocortisone 1% can lead to ear-
lier improvement of the condition; however, hydrocortisone 1% and In conclusion, the results of the current study agree with those of
sertaconazole 2% eventually show similar therapeutic responses after similar trials that researched topical sertaconazole 2% as treatment
4 weeks of treatment. Patients global satisfaction with treatment also for patients with SD. The limitations of this work include the small
suggested similar results in both groups (Fig. 2). number of patients who were recruited for the study and the lack
Sertaconazole is an antifungal agent of the imidazole class that has of evaluation of time to relapse. Despite these limitations, the efcacy
antibacterial, anti-inammatory, and antipruritic potential (Carrillo- of sertaconazole to treat patients with SD and its lower side effects
Muoz et al., 2011). Given the chronicity of SD, long-term treatment provide enough rationale to assess the use of topical sertaconazole
with topical agents is almost always the need of the hour. Our nd- in larger, longer-term, randomized, double-blind trials. Because the
ings indicate that topical sertaconazole has an effect that is equal to chronicity of SD requires long-term treatment to maintain disease
treatment with topical hydrocortisone in clearing of SD lesions. This control, topical sertaconazole, which has similar effect and lower ad-
is an important observation because sertaconazole has fewer verse events compared with topical steroid therapies, may be
medication-related adverse effects with long-term treatment. regarded as an excellent substitute for topical steroids in the treat-
Our results are similar to those from previous studies that evalu- ment of patients with SD if proven to have the same efcacy in
ated the efcacy of topical sertaconazole in patients with SD long-term trials.
Chart Title
6
patient assessment
0
0 2 4
time(weeks)
hydrocortisone 1% sertaconazole 2%
Fig. 2. Within-group decrease in patient satisfaction from baseline to study end (p b .05 for both treatment groups). There was no signicant difference between the treatment
groups at any timepoint.
Please cite this article as: Balighi K, et al, Hydrocortisone 1% cream and sertaconazole 2% cream to treat facial seborrheic dermatitis: A double-
blind, randomized clinical trial, International Journal of Women's Dermatology (2016), http://dx.doi.org/10.1016/j.ijwd.2016.11.008
4 K. Balighi et al. / International Journal of Women's Dermatology xxx (2016) xxxxxx
References Goldust M, Rezaee E, Rouhani S. Double blind study of sertaconazole 2% cream vs. clo-
trimazole 1% cream in treatment of seborrheic dermatitis. Ann Parasitol 2013;59:
259.
Bikowski J. Facial seborrheic dermatitis: a report on current status and therapeutic ho- Gupta AK, Bluhm R. Seborrheic dermatitis. J Eur Acad Dermatol Venereol 2004;18:
rizons. J Drugs Dermatol 2009;8:12533. 1326.
Carrillo-Muoz AJ, Tur-Tur C, Crdenes DC, Estivill D, Giusiano G. Sertaconazole nitrate Koca R, Altinyazar HC, Etrk E. Is topical metronidazole effective in seborrheic derma-
shows fungicidal and fungistatic activities against Trichophyton rubrum, titis? A double-blind study. Int J Dermatol 2003;42:6325.
Trichophyton mentagrophytes, and Epidermophyton occosum, causative agents Naldi L, Rebora A. Clinical practice. Seborrheic dermatitis. N Engl J Med 2009;360:
of tinea pedis. Antimicrob Agents Chemother 2011;55:44201. 38796.
Dessinioti C, Katsambas A. Seborrheic dermatitis: Etiology, risk factors, and treat- Papp KA, Papp A, Dahmer B, Clark CS. Single-blind, randomized controlled trial evalu-
ments: Facts and controversies. Clin Dermatol 2013;31:34351. ating the treatment of facial seborrheic dermatitis with hydrocortisone 1% oint-
Elewski BE, Cantrell WC. An open-label study of the safety and efcacy of ment compared with tacrolimus 0.1% ointment in adults. J Am Acad Dermatol
sertaconazole nitrate in the treatment of seborrheic dermatitis. J Drugs Dermatol 2012;67:e115.
2011;10:8959. Rovelli F, Mercuri SR, Naldi L. Seborrheic dermatitis in clinical practice. Recenti Prog
Firooz A, Solhpour A, Gorouhi F, Daneshpazhooh M, Balighi K, Farsinejad K, et al. Med 2011;102:12633.
Pimecrolimus cream, 1%, vs hydrocortisone acetate cream, 1%, in the treatment Schmidt JA. Seborrheic dermatitis: A clinical practice snapshot. Nurse Pract 2011;36:
of facial seborrheic dermatitis: a randomized, investigator-blind, clinical trial. 327.
Arch Dermatol 2006;142:10667. Schwartz RA, Janusz CA, Janniger CK. Seborrheic dermatitis: An overview. Am Fam
Goldust M, Rezaee E, Masoudnia S, Raghifar R. Clinical study of sertaconazole 2% cream Physician 2006;74:12530.
vs. hydrocortisone 1% cream in the treatment of seborrheic dermatitis. Ann Weinberg JM, Koestenblatt EK. Treatment of interdigital tinea pedis: Once-daily ther-
Parasitol 2013;59:11923. apy with sertaconazole nitrate. J Drugs Dermatol 2011;10:113540.
Please cite this article as: Balighi K, et al, Hydrocortisone 1% cream and sertaconazole 2% cream to treat facial seborrheic dermatitis: A double-
blind, randomized clinical trial, International Journal of Women's Dermatology (2016), http://dx.doi.org/10.1016/j.ijwd.2016.11.008