Clobetasol-17-propionate

Author: Prof. Dr. med. Peter Altmeyer

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Last updated on: 29.09.2023

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Synonym(s)

Clobetasol propionate cream 005% hydrophilic (NRF 11.76.); Salicyl Tar Clobetasol Ointment

Definition
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Strongly potent halogenated glucocorticoid (class IV), mostly used in the form of clobetasol-17-propionate. The optimum stability of clobetasol-17-propionate is pH 4-6. At higher pH values, hydrolysis of the ester occurs. Therefore, a citrate buffer should be added to all formulations, consisting of equal amounts of a 0.5% citric acid solution and a 0.5% sodium citrate solution and having a pH of 4.2. On the total formulation, the citrate buffer is used at 5%. The addition of salicylic acid or urea in clobetasol-17-propionate preparations is controversial.

Indication
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Eczema. Psoriasis vulgaris and other inflammatory skin diseases.

Dosage and method of use
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Ointment/cream/compound: Apply thinly 1-2 times/day to the affected skin areas.

Notice!

Application duration max. 2-3 weeks!

Standard concentration
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0.05% (upper recommended concentration) in ointments, creams and solutions.

Undesirable effects
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Allergic side effects to clobetasol-17-propionate are very rare. DKG has tested clobetasol-17-propionate 0.25% in vaseline so far. This form of application is no longer available as a test substance in Germany. In this respect, a 1% concentration of clobetasol-17-propionate in vaseline is now recommended (as of 2016).

Skin atrophy may occur, especially with prolonged, uncontrolled application. With prolonged application to large areas, the active ingredient can be absorbed through the skin and become systemically active. In order to avoid consequences such as a Cushing's syndrome and disturbances of the hormone balance, the treatment should be narrowly limited in time.

Contraindication
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Children < 2 years, application on the eye.

Recipe(s)
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  • R229; R054; R054a
  • 0.05% Clobetasol urea lotion
    • clobetasol-17-propionate 0,05
    • Hydrophilic urea emulsion 5% (NRF 11.72) ad 100,0
    • S: 0,05% Clobetasol-urea lotion; use-up period 6 months. Shake mix bottle with hinged lid.
  • 0.05% Clobetasol lotion
    • clobetasol-17-propionate 0,05
    • Sol. acid. citric. 0.5% 2.5
    • Sol natr. citric. 0.5% 2.5
    • Ung. emulsific. aquos. 29,0
    • Potassium sorbicum 1,0
    • Aqua purific. ad 100,0
    • S: 0.05% Clobetasol lotion; use-by period 6 months. Shake-mixture bottle with hinged closure.

Preparations
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Clobegalen, Dermoxin, Dermoxinale, Karison, Clobex Shampoo

Note(s)
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Clobetasol propionate has an optimum pH stability of pH 4-6 in aqueous solutions, and hydrolysis takes place in a strongly acidic or basic environment, with the propionic acid residue being split off and a considerable loss of efficacy. For this reason, a citrate buffer with a pH of 4.2 must be added in magistral formulations (0.5% citric acid + 0.5% sodium citrate solution mixed in equal parts to a total of 5% based on the total amount of the formulation).

Literature
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  1. Geier J et al (2016) News on the epicutaneous test series of the German Contact Allergy Group. Dermatology at work and in the environment 64: 70-75
  2. Wolf G (2011) Changes to a vehicle system. Dermatologist 62: 410-411

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Last updated on: 29.09.2023