CLOBETASOL SUMMARY
Clobetasol propionate foam, 0.05% contains clobetasol propionate, USP, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.
Clobetasol propionate foam, 0.05% is a super-potent topical corticosteroid indicated for short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid- responsive dermatoses of the scalp, and for short-term topical treatment of mild to moderate plaque-type psoriasis on non-scalp regions excluding the face and intertriginous areas.
Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. In a controlled pharmacokinetic study, some subjects experienced reversible suppression of the adrenals following 14 days of clobetasol propionate foam, 0.05% therapy (See
ADVERSE REACTIONS).
Use in children under 12 years of age is not recommended.
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NEWS HIGHLIGHTS
Published Studies Related to Clobetasol (Clobetasol Topical)
Clobetasol propionate, 0.05%, vs hydrocortisone, 1%, for alopecia areata in
children: a randomized clinical trial. [2014] IMPORTANCE: Alopecia areata is an idiopathic cause of hair loss with limited
therapeutic repertoire. OBJECTIVE: To compare the efficacy and safety of a high- vs low-potency topical
corticosteroid in pediatric patients...
A comparative study in efficacy and safety of 0.1% tacrolimus and 0.05%
clobetasol propionate ointment in discoid lupus erythematosus by modified
cutaneous lupus erythematosus disease area and severity index. [2012] CONCLUSION: The present study proved the efficacy of twice-daily tacrolimus and
A double-blind, randomized, placebo-controlled trial of topical tacrolimus 0.1% vs. clobetasol propionate 0.05% in childhood vitiligo. [2011.09] BACKGROUND: Both clobetasol propionate 0.05% (CP 0.05%) and tacrolimus 0.1% (T 0.1%) ointments have been shown to be efficacious and safe in treating vitiligo in the paediatric population. OBJECTIVES: To assess efficacy and safety of these two therapies compared with each other and with placebo... CONCLUSIONS: Both CP 0.05% and T 0.1% ointments offer similar benefit in paediatric vitiligo, both facial and nonfacial. The facial lesions responded faster than the nonfacial ones. (c) 2011 The Authors. BJD (c) 2011 British Association of Dermatologists.
Clobetasol propionate 0.05% spray for the management of moderate-to-severe plaque psoriasis of the scalp: results from a randomized controlled trial. [2011.08] BACKGROUND: Clobetasol propionate 0.05% spray is available for treating moderate-to-severe plaque psoriasis; however, there is limited information with plaque psoriasis of the scalp. OBJECTIVE: Evaluate the efficacy, safety, and quality-of-life impact of clobetasol propionate 0.05% spray in patients with moderate to severe plaque psoriasis of the scalp... CONCLUSION: Treatment with clobetasol propionate 0.05% spray for up to four weeks is effective and well tolerated for moderate-to-severe plaque psoriasis of the scalp.
Comparison of clobetasol propionate cream plus coal tar vs. topical psoralen and solar ultraviolet A therapy in palmoplantar psoriasis. [2011.08] AIM: Palmoplantar psoriasis (PPP) produces significant morbidity and requires prompt treatment. Topical agents form the mainstay of therapy. We compared the efficacy and side-effect profile of a steroid/coal-tar combination with topical psoralen and solar ultraviolet A (PUVAsol) in PPP... CONCLUSION: Both treatments had comparable efficacy. In both groups, patients experienced 'good improvement' after 16 weeks of therapy. (c) The Author(s). CED (c) 2011 British Association of Dermatologists.
Clinical Trials Related to Clobetasol (Clobetasol Topical)
Comparison of Efficacy of Intralesional Triamcinolone Injection and Clobetasol Propionate Ointment for Psoriatic Nails [Completed]
Psoriatic nails can significantly affect a quality of life of patients. Psoriasis affects
both nail matrix and nail bed. Pitting, leukonychia and red spots in lunula indicate a
defect in the nail matrix. Psoriasis can change the nail bed as the results in onycholysis,
discoloration, splinter hemorrhage and subungual hyperkeratosis. The main treatment of
psoriatic nails is using topical high- potent steroids however topical steroids are limited
their ability to penetrate deep nail matrix or nail bed which are the main pathology. Use of
such a treatment can lead to skin atrophy and report in the case of "Disappearing digits".
Previous studies of steroid injection in the treatment of psoriatic nails show satisfactory
results without any serious permanent adverse effects. At present, there is no comparison
study between intralesional steroid and ultrapotent topical steroid for the treatment of
psoriatic nails.
The purpose of the study is to evaluate the efficacy and safety of intralesional
triamcinolone comparing to 0. 05% clobetasol ointment in the treatment of psoriatic nails.
Clobetasol for Oral Graft-Versus-Host Disease [Recruiting]
Background:
- Oral graft-versus-host disease (GVHD) is a possible complication of bone marrow
transplants. It is the result of the donor cells trying to attack the recipient s body.
Symptoms include dry mouth, sensitivity and pain when tasting certain spices and flavors,
and painful swallowing. Steroids are a possible effective treatment for GHVD, but they can
cause side effects when given as pills or injections. Steroids given in a cream or rinse
form, applied directly to the site of the symptoms, can have fewer side effects. However,
their effectiveness as a rinse has not been tested in the mouth. Researchers want to see if
a steroid called clobetasol can be used as a mouth rinse to treat oral GHVD.
Objectives:
- To see if a clobetasol rinse is a safe and effective treatment for oral graft-versus-host
disease.
Eligibility:
- Individuals at least 12 years of age who have oral GHVD and are not allergic to
clobetasol.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine
samples will be collected. They will also have an oral exam, a mouth tissue biopsy, and
other tests before starting the study drug.
- Participants will be separated into two groups. One group will receive clobetasol; the
other will have a placebo liquid.
- Participants will rinse their mouths with the study liquid three times a day after
meals for 2 weeks.
- After 2 weeks, participants will have another study visit with blood tests and other
exams.
- After the study visit, all participants will start to use the clobetasol rinse. Those
who originally had clobetasol will use the rinse for another 2 weeks. Those who
originally had a placebo will use the rinse for 4 weeks.
- Participants will have a follow-up exam after the end of treatment.
Efficacy/Safety/Subject Satisfaction/Duration of Response of Clobetasol Propionate Spray vs Ointment in Plaque Psoriasis [Completed]
This study is a comparison between Clobetasol Propionate Spray and Clobetasol Propionate
Ointment with Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in
Moderate to Severe Stable Plaque Psoriasis. Subjects will be enrolled and randomized into
one of two groups: clobetasol propionate Spray for 4 weeks of treatment or clobetasol
propionate ointment for 2 weeks of treatment with a 2 week follow-up visit for each group.
Pivotal Bioequivalence Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects [Completed]
To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0. 05%
lotions in asymptomatic subjects.
Evaluation of the Efficacy and Tolerability of Clobetasol Propionate Foam Compared to Vehicle Foam [Completed]
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