• 
• 

Three Part Question

In [infants with seborrhoeic dermatitis] is there any advantage to using [antifungals over steroids] to [cure seborrhoeic dermatitis of the scalp and prevent recurrences]?

Clinical Scenario

A mother presents an infant to you with unsightly seborrhoeic dermatitis on his/her scalp. You prescribe 1% hydrocortisone but the mother expresses her unhappiness at using steroids. You remember that the dermatologists at your hospital like to use an antifungal cream and you decide to find out more.

Search Strategy

Medline 1966-2003 (OVID). Cochrane database and Best Bets website under keyword "seborrhoeic".
Subject heading "Seborrhoeic Dermatitis" + subheadings "Therapy AND Drug Therapy"

Search Outcome

556 articles produced and sorted manually. 5 relevant from medline. Cochrane and BestBETS none extra.

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Pari et al 1988 India	36 Adult patients with face and trunk seborrhoeic dermatitis. Randomised to 2% ketoconazole v 0.05% clobetasol BD for 4 weeks	Randomised double blind trial (level 1b)	Resolution at 4 weeks	Effective remission in both groups (ketoconazole 64.7%, clobetasone 63.2%). ARR -0.015 95% CI –0.33 to 0.30.	Not applied to scalp (coal tar shampoo given if scalp affected). No comparison of patient characteristics. Small numbers in trial.
			Recurrence at 3 months	Recurrence rates 30% ketoconazole and 50% steroid. ARR 0.180 95% CI -0.13 to 0.49.
Ortonne JP et al, 1992, France	62 adult patients with scalp seborrhoeic dermatitis and other locations. Randomised to 2% ketoconazole foaming gel or betamethasone in reducing course over 4 months.	Randomised single blind trial (level 1b)	Resolution at 1 and 4 months	Effective remission in both groups at 1 month (ketoconazole 90%, betamethasone 73%). ARR 0.226 95% CI –0.44 to 0.90. At 4 months ketoconazole 89%, betamethasone 62%. ARR 0.290 95% CI 0.09 to 0.49.	Adverse effects greater in betamethasone group (52% v 16%) NNT 3
			Recurrence	Recurrence rates similar 70% ketoconazole and 86% betamethasone. ARR 0.153 95% CI -0.08 to 0.38.
Stratigos JD et al, 1988, Greece	78 adult patients with seborrhoeic dermatitis. Randomised to 2% ketoconazole cream or 1% hydrocortisone cream OD for 4 weeks	Randomised double blind trial (level 1b)	Response of seborrhoeic dermatitis at 2 and 4 weeks	At 4 weeks effective remission in both groups (ketoconazole 81%, hydrocortisone 94%). ARR -0.139 95% CI –0.29 to 0.01.	2 week result similar Low incidence of side effects in both groups
Faergemann J, 1986,	70 adult patients with scalp seborrhoeic dermatitis. Randomised to 2% miconazole, 1% hydrocortisone or Daktacort combination OD for 3 weeks and then if no cure for a further 3 weeks	Randomised double blind trial (level 1b)	Resolution at 3 weeks	At 3 weeks poor remission in all groups (miconazole 33%, hydrocortisone 33%). ARR –0.116 95% CI -0.15 to –0.01.	No details of randomisation Interesting look at steroid-fungicide combination
			Resolution at 6 weeks	At 6 weeks improved remission in all groups (miconazole 68%, hydrocortisone 71%). ARR –0.027 95% CI -0.19 to 0.13.
			Recurrence after using same solution in patients achieving remission twice monthly for 3 months	Risk of recurrence higher in miconazole group (hydrocortisone 82%, miconazole 33%). ARR 0.452 95% CI 0.22 to 0.67
Katsambas A et al, 1989, Greece	50 adult patients with seborrhoeic dermatitis. Randomised to 2% ketoconazole cream or 1% hydrocortisone cream BD for 4 weeks	Randomised double blind trial (level 1b)	Response at 4 weeks	Effective response in both groups (ketoconazole 83%, hydrocortisone 96%. ARR –0.128 95% CI -0.30 to 0.04.	Low incidence of side effects in both groups. No details of randomisation. No comparison of patient characteristics.
Zeharia A et al, 1995, Israel	36 children from 1 month to 10 years (mean 17 months) with scalp seborrhoeic dermatitis treated with bifonazole 1% shampoo 3 times a week for 4 weeks	Poor quality cohort study (level 4)	Resolution at 4 weeks	71% patients cured at 4 weeks	No randomisation or placebo comparator. Experimenters assumed in conclusion that the high rate of cures makes analysis 'straightforward and self-evident'

Comment(s)

Seborrhoeic dermatitis is a common benign condition of childhood. Often the most appropriate treatment is to do nothing however, children with scalp seborrhoeic dermatitis still make regular presentations to paediatric outpatient clinics with disease burden enough to warrant treatment. The link between the excessive presence of pityrosporum ovale yeast to seborrhoeic dermatitis is well documented in the literature and it is intuitive that using a pityrosporicidal agent would not only treat the condition, but help prevent recurrences. Both fungicides and steroids have been shown to be effective in the treatment of seorrhoeic dermatitis when compared to placebo. 5 trials of good quality were found directly comparing topical steroids with topical fungicides. At one month of treatment, four of the trials demonstrated good effectiveness of both treatments and no significant differences between them. One trial, (Ortonne et al) showed a very slight improvement in the ketoconazole group over the steroid group. The trials reviewed are all on adults as there are no comparable trials in infants. However the extrapolation to this age group is viable as the disease is similar. Only one paper, (Zeharia et al), with a specifically paediatric age group could be found and the quality was too low to allow meaningful analysis. The three studies which also looked at the recurrence rate showed similar results in two and a slight advantage in using ketoconazole in one. Two trials noted low and similar incidence of side effects and one, (Ortonne et al) demonstrated a much better tolerance of the antifungal over the steroid. There is no clear consensus on treatment regimen. However a four week course was shown to be effective in 4 of the trials using a once or twice a day regimen. There has been a paper published on the safety of ketoconazole in infants (Brodell et al) which demonstrated that a course of ketoconazole twice a week for four weeks produced no detectable serum ketoconazole levels and no change in LFTs.

Clinical Bottom Line

Ketoconazole is at least as effective at treating seborrhoeic dermatitis as steroid creams and may be better at preventing recurrences providing a good alternative to using steroid creams in infants.

References

1. Pari T. Pulimood S. Jacob M. George S. Jeyaseelan L. Thomas K. Randomised double blind controlled trial of 2% ketoconazole cream versus 0.05% clobetasol 17-butyrate cream in seborrhoeic dermatitis. Journal of the European Academy of Dermatology and Venereology. 10(1):89-90, 1988 Jan.
2. Ortonne JP, Lacour JP, Vitetta A et al. Comparative study of ketoconazole 2% foaming gel and betamethasone dipropionate 0.05% lotion in the treatment of seborrhoeic dermatitis in adults. Dermatology 1992;184(4):275-80.
3. Stratigos JD, Antoniou C, Katsambas A et al. Ketoconazole 2% cream versus hydrocortisone 1% cream in the treatment of seborrhoeic dermatitis. A double-blind comparative study. J Am Acad Dermatol 1988;19(5 Pt 1):850-3.
4. Faergemann J. Seborrhoeic dermatitis and Pityosporum obiculare: treatment of seborrhoeic dermatitis of the scalp with miconazole-hydrocortisone (Daktacort), miconazole and hydrocortisone. Br J Dermatol 1986;114(6):695-700.
5. Katsambas A, Antoniou C, Frangouli E et al. A double-blind trial of treatment of seborrhoeic dermatitis with 2% ketoconazole cream compared with 1% hydrocortisone cream. Br J Dermatol 1989;121(3):353-7.
6. Zeharia A, Mimouni M, Fogel D. Treatment with bifonazole shampoo for scalp seborrhoea in infants and young children. Paediatr Dermatol 1996;13(2):151-153.
7. Brodell R, Patel S, Venglarick J, et al. The safety of ketoconazole shampoo for infantile seborrheic dermatitis. Pediatr Dermatol 1988;15(5):406-407.