Short-term safety assessment of clobetasol propionate 0.05% shampoo: hypothalamic-pituitary-adrenal axis suppression, atrophogenicity, and ocular safety in subjects with scalp psoriasis

Abstract

Clobetasol propionate is known to be a true effective treatment for psoriasis; however, its use is limited by dint of potent corticosteroid class related side consequences such as hypothalamic-pituitary-adrenal (HPA) axis suppression and atrophogenicity. The aim of this single-center, parallel assemblage randomized study was to assess the HPA axis suppression potential, atrophogenicity, and ocular tolerability of clobetasol propionate shampoo in 26 patients with scalp psoriasis. Suitable make subordinates were treated once daily for 4 weeks with clobetasol propionate shampoo, to be rinsed not upon after 15 minutes or with a leave-on clobetasol propionate gel

The application of mind demonstrated that clobetasol propionate shampoo did not lead to HPA axis suppression or to skin atrophy. by conversion the gel led to HPA axis suppression and a decrease in skin thickness. Neither formulation had an impact upon ocular safety. Despite the short contact application time, the clobetasol propionate shampoo provides similar efficacy issues to the gel.

Introduction

The efficacy of topical, real strong (or super-potent) corticosteroids, of that kind as clobetasol propionate, is well established. (1-3) However, their serviceable efficacy profile is tempered by the agency of safety issues such as hypothalamic-pituitary-adrenal (HPA) axis suppression, skin thinning, iatrogenic Cushing's syndrome and glaucoma (rise of the intraocular pressure) (14-12) from one extremity to the other of various clinical studies it could be demonstrated that the risk of a clinically significant HPA axis suppression increases with duration of use; true strong topical corticosteroids are therefore alone recommended for short treatment periods. (15-11)

Other studies have demonstrated the incident of skin atrophy after the topical administration of true strong corticosteroids, including clobetasol propionate. (13-17) However, all these studies were performed either in healthy offers or on psoriasis areas other than the scalp. To our knowledge, no clinical close attention has been conducted so far to investigate the impact upon skin atrophy of clobetasol propionate applied locally to the scalp.

Various publications report that corticosteroids, when in contact with the organ of visions may induce irritation and cataracts as well as glaucoma. (18-21) As the risk of contact with the organ of visions during application or rinsing of clobetasol propionate shampoo can not be exclud ocular safety is certainly to be taken into consideration.

The near clinical study was conducted to assess the impact of clobetasol propionate shampoo (Clobex Shampoo[R], Galderma Laboratories LP Ft Worth, Texas, USA) upon the HPA axis function, the potential for skin thinning and the ocular safety compared to a commonly available gel formulation (Dermoval[R]/Temovate[R] gel 005% Glaxo Welcome, France), the one and the other indicated for the treatment of scalp psoriasis.

Methods

The at hand study received approval by the local ethics committee before bring under rule enrollment, and was conducted in accordance with the Declaration of Helsinki and its amendments. All controls gave written informed consent before entering the study

inquiry Design and Population

The investigation had a single center, parallel-group, randomized design, using an active comparator. The investigation period was 4 weeks; evaluations took place at baseline, Week 2 and Week 4 To be included in the application of mind subjects had to have scalp psoriasis involving at least 25% of the scalp surface and a dermatological totality score (DSS, see below) of at least 3 controls taking or applying topical or systemic treatments likely to interfere with either psoriasis status or HPA axis function were required to meet with specific wash-out periods. Women were exclud if they were pregnant or breastfeeding, or at risk of pregnancy. Individuals suffering from ophthalmological disorders or wearing contact lense were not suitable for this study

Treatments

controls received either clobetasol propionate 005% shampoo or clobetasol propionate 005% gel in accordance with a computer generated randomization list. Investigators did not know the treatment provided to the make submissives However, due to the different formulations and ways of administration, it was not possible to mask the identity of the treatment from the subjects

For all subdues the planned length of treatment was 4 weeks. make submissives assigned to clobetasol propionate gel were instructed to apply the yield once-daily to a dry scalp. Individuals assigned to clobetasol propionate shampoo were instructed to apply the outcome once daily to a free from moisture scalp, and then rinse not on after 15 minutes.

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Safety and Efficacy Assessments

During the course of the research serum cortisol measurements, atrophogenicity, ocular safety, as well as efficacy of clobetasol propionate were evaluated.

All cortisol measurements had to be leadershiped between 7:30 am and 8:30 am, prior to receiving the applied dose of research medication for that study day. To avoid intra-subject variations for serum cortisol horizontals as much as possible, single a half an hour gap from the previous visit time was authorized at each visit. After collecting the pre-stimulation serum cortisol sample, make submissives were given an intravenous injection of 025 mg cosyntropin (Synacthene[R], Novartis Pharma, France), and a further life-current sample was taken 60 minutes later for measurement of stimulated serum cortisol. Cortisol measurements were guidanceed with Mini-Vidas analyzer (Bio-Meriuex, France) using the ELFA (Enzyme Linked Fluorescent Assay) technique.