monitoring by the clinician, with vigilance regarding potential
local and systemic adverse reactions.
In cutaneous safety studies, the skin irritancy potential of
clocortolone pivalate 0.1% cream was determined to be
neglibible.11 In one study (n=10) of extensive application of
clocortolone pivalate 0.1% cream (30g twice daily) to subjects
over 21 days with 12 hours of full body occlusion each day,
suppression of the hypothalamic-pituitary-adrenal (HPA) axis
was not observed using urinary 17-ketosteroid and serum cortisol
levels at specified timepoints.11 Other studies have shown
that clocortolone pivalate 0.1% cream does not induce phototoxicity
This article discusses compound-related properties, vehicle
characteristics, and efficacy and safety data which demonstrate
that clocortolone pivalate 0.1% cream exhibits favorable pharmacologic
properties, efficacy outcomes, and tolerability data.
In addition, the emollient cream vehicle is well-designed for application
to eczematous and inflamed skin as supported both
by clinical experience and by studies evaluating favorable effects
on TEWL and skin hydration (corneometry). It is beneficial
for clinicians to be aware that an authorized generic of clocortolone
pivalate 0.1% cream has been made available from
the same manufacturer as the original brand of clocortolone
pivalate 0.1% cream, with both being identical in their formulation.
This assures that substitution with this specific authorized
generic of clocortolone pivalate 0.1% cream does not change
what the patient is receiving as compared to the brand formulation
of clocortolone pivalate 0.1% cream.
This publication was supported by Promius Pharma, LLC.
Dr. Del Rosso has served as a consultant, advisory board participant,
clinical investigator, and speaker for Allergan, Anacor
Aqua, Bayer Healthcare (Dermatology), Dermira, Eisai, Ferndale,
Galderma, Innocutis, LeoPharma, Merz Pharmaceuticals,
Onset Dermatologics, Pharmaderm, Primus, Promius Pharma,
Quinnova, Ranbaxy, Sebacea, Taro, Unilever, and Valeant Pharmaceuticials
(Medicis, Consumer Care), and Warner-Chilcott.
Dr. Kircik has served as an advisor, investigator, consultant, and
speaker for Allergan, Bayer, Galderma, Promius Pharma, Quinnova,
Stiefel/GSK, LeoPharma, Taro, Valeant, and Warner-Chilcott.
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James Q. Del Rosso DO FAOCDjqdelrosso@yahoo.com