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Efficacious and safe management of moderate to severe scalp seborrhoeic dermatitis using clobetasol propionate shampoo 0·05% combined with ketoconazole shampoo 2%: a randomized, controlled study.
Br J Dermatol. 2011 Jul; 165(1):171-6.BJ

Abstract

BACKGROUND

Topical antifungals and corticosteroids are the mainstay of treatment for seborrhoeic dermatitis. The short-contact clobetasol propionate 0·05% shampoo (CP) is an efficacious and safe once-daily treatment for scalp psoriasis.

OBJECTIVES

To evaluate the efficacy and safety of CP alone and combined with ketoconazole shampoo 2% (KC) in the treatment of moderate to severe scalp seborrhoeic dermatitis.

METHODS

This randomized and investigator-blinded study consisted of three phases, each lasting 4 weeks. During the treatment phase, subjects were randomized to receive KC twice weekly (K2), CP twice weekly (C2), CP twice weekly alternating with KC twice weekly (C2 + K2) or CP four times weekly alternating with KC twice weekly (C4+K2). All subjects received KC once weekly during the maintenance phase and were untreated during the follow-up phase.

RESULTS

At the end of the treatment phase, all three CP-containing regimens were significantly more efficacious than K2 in decreasing the overall disease severity (P < 0·05). Both combination regimens were also significantly more efficacious than K2 in decreasing each individual sign of the disease (P < 0·05). While the C2 and C4 + K2 groups experienced slight worsening during the maintenance phase, the efficacy of C2 + K2 was sustained and remained the highest among all groups. All regimens were well tolerated without inducing any skin atrophy. Similarly low incidences of telangiectasia, burning and adverse events were observed among the four groups.

CONCLUSIONS

The combination therapy of twice-weekly CP alternating with twice-weekly KC provided significantly greater efficacy than KC alone and a sustained effect in the treatment of moderate to severe scalp seborrhoeic dermatitis.

Links

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Authors+Show Affiliations

Ortonne JP
Hôpital de l'Archet 2, 06202 Nice Cedex 3, France. ortonne@unice.fr
Nikkels AF
No affiliation info available
Reich K
No affiliation info available
Ponce Olivera RM
No affiliation info available
Lee JH
No affiliation info available
Kerrouche N
No affiliation info available
Sidou F
No affiliation info available
Faergemann J
No affiliation info available

MeSH

Administration, CutaneousAdultAnti-Inflammatory AgentsAntifungal AgentsClobetasolDermatitis, SeborrheicDermatologic AgentsDrug CombinationsFemaleHumansKetoconazoleMaleMiddle AgedScalp DermatosesSeverity of Illness Index

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21707573

Clinical Trial Links

Clinical trial which this article describes

Citation

Ortonne, J-P, et al. "Efficacious and Safe Management of Moderate to Severe Scalp Seborrhoeic Dermatitis Using Clobetasol Propionate Shampoo 0·05% Combined With Ketoconazole Shampoo 2%: a Randomized, Controlled Study." The British Journal of Dermatology, vol. 165, no. 1, 2011, pp. 171-6.
Ortonne JP, Nikkels AF, Reich K, et al. Efficacious and safe management of moderate to severe scalp seborrhoeic dermatitis using clobetasol propionate shampoo 0·05% combined with ketoconazole shampoo 2%: a randomized, controlled study. Br J Dermatol. 2011;165(1):171-6.
Ortonne, J. P., Nikkels, A. F., Reich, K., Ponce Olivera, R. M., Lee, J. H., Kerrouche, N., Sidou, F., & Faergemann, J. (2011). Efficacious and safe management of moderate to severe scalp seborrhoeic dermatitis using clobetasol propionate shampoo 0·05% combined with ketoconazole shampoo 2%: a randomized, controlled study. The British Journal of Dermatology, 165(1), 171-6. https://doi.org/10.1111/j.1365-2133.2011.10269.x
Ortonne JP, et al. Efficacious and Safe Management of Moderate to Severe Scalp Seborrhoeic Dermatitis Using Clobetasol Propionate Shampoo 0·05% Combined With Ketoconazole Shampoo 2%: a Randomized, Controlled Study. Br J Dermatol. 2011;165(1):171-6. PubMed PMID: 21707573.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacious and safe management of moderate to severe scalp seborrhoeic dermatitis using clobetasol propionate shampoo 0·05% combined with ketoconazole shampoo 2%: a randomized, controlled study. AU - Ortonne,J-P, AU - Nikkels,A F, AU - Reich,K, AU - Ponce Olivera,R M, AU - Lee,J H, AU - Kerrouche,N, AU - Sidou,F, AU - Faergemann,J, PY - 2011/6/29/entrez PY - 2011/6/29/pubmed PY - 2011/9/15/medline SP - 171 EP - 6 JF - The British journal of dermatology JO - Br J Dermatol VL - 165 IS - 1 N2 - BACKGROUND: Topical antifungals and corticosteroids are the mainstay of treatment for seborrhoeic dermatitis. The short-contact clobetasol propionate 0·05% shampoo (CP) is an efficacious and safe once-daily treatment for scalp psoriasis. OBJECTIVES: To evaluate the efficacy and safety of CP alone and combined with ketoconazole shampoo 2% (KC) in the treatment of moderate to severe scalp seborrhoeic dermatitis. METHODS: This randomized and investigator-blinded study consisted of three phases, each lasting 4 weeks. During the treatment phase, subjects were randomized to receive KC twice weekly (K2), CP twice weekly (C2), CP twice weekly alternating with KC twice weekly (C2 + K2) or CP four times weekly alternating with KC twice weekly (C4+K2). All subjects received KC once weekly during the maintenance phase and were untreated during the follow-up phase. RESULTS: At the end of the treatment phase, all three CP-containing regimens were significantly more efficacious than K2 in decreasing the overall disease severity (P < 0·05). Both combination regimens were also significantly more efficacious than K2 in decreasing each individual sign of the disease (P < 0·05). While the C2 and C4 + K2 groups experienced slight worsening during the maintenance phase, the efficacy of C2 + K2 was sustained and remained the highest among all groups. All regimens were well tolerated without inducing any skin atrophy. Similarly low incidences of telangiectasia, burning and adverse events were observed among the four groups. CONCLUSIONS: The combination therapy of twice-weekly CP alternating with twice-weekly KC provided significantly greater efficacy than KC alone and a sustained effect in the treatment of moderate to severe scalp seborrhoeic dermatitis. SN - 1365-2133 UR - https://www.unboundmedicine.com/medline/citation/21707573/Efficacious_and_safe_management_of_moderate_to_severe_scalp_seborrhoeic_dermatitis_using_clobetasol_propionate_shampoo_0·05_combined_with_ketoconazole_shampoo_2:_a_randomized_controlled_study_ L2 - https://doi.org/10.1111/j.1365-2133.2011.10269.x DB - PRIME DP - Unbound Medicine ER -