Clindagel (Clindamycin Phosphate Topical Gel) - Summary

CLINDAGEL SUMMARY

Clindagel^® (clindamycin phosphate gel) topical gel, 1%, a topical antibiotic, contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram in a gel vehicle consisting of carbomer 941, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water.

Clindagel^® is indicated for topical application in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (See CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS.)

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NEWS HIGHLIGHTS

Media Articles Related to Clindagel (Clindamycin Topical)

EMA: Benefits Outweigh VTE Risks With Hormone Drugs for Acne
Source: Medscape Medical News Headlines [2013.05.17]
The EMA has issued a recommendation that the benefits of the hormonal acne treatment Diane and its generics outweigh the risks, provided that several measures are taken to minimize the risk of thromboembolism.
International Approvals

Research Letter Suggests Twitter May Serve As A Good Forum For Communicating Information About Acne
Source: Health News from Medical News Today [2013.05.17]
JAMA Dermatology Study Highlights A research letter by Kamal Jethwani, M.D., M.P.H., of the Center for Connected Health, Boston, and colleagues suggests that clinicians can learn about the perceptions and misconceptions of diseases like acne via Twitter, and communicate reliable medical information on the popular social media platform...

Pediatricians Endorse New Acne Treatment Guidelines
Source: MedicineNet Acne Specialty [2013.05.06]
Title: Pediatricians Endorse New Acne Treatment Guidelines
Category: Health News
Created: 5/6/2013 10:35:00 AM
Last Editorial Review: 5/6/2013 12:00:00 AM

Tx for Pediatric Acne Gets New Guidance (CME/CE)
Source: MedPage Today Dermatology [2013.05.04]
(MedPage Today) -- Typically seen as a teenager's disease, acne also presents in children and infants, and treatments should be age appropriate, according to new recommendations from the American Acne and Rosacea Society.

With Acne, Bacteria Strain on Your Skin May Be Culprit
Source: MedicineNet Acne Specialty [2013.02.28]
Title: With Acne, Bacteria Strain on Your Skin May Be Culprit
Category: Health News
Created: 2/28/2013 10:35:00 AM
Last Editorial Review: 2/28/2013 12:00:00 AM

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Published Studies Related to Clindagel (Clindamycin Topical)

A randomized, double-blind, placebo-controlled, pilot study to assess the efficacy and safety of clindamycin 1.2% and tretinoin 0.025% combination gel for the treatment of acne rosacea over 12 weeks. [2012]
rosacea after 12 weeks of usage... CONCLUSIONS: A combination gel of clindamycin phosphate 1.2% and tretinoin 0.025%

Efficacy and safety of topical nadifloxacin and benzoyl peroxide versus clindamycin and benzoyl peroxide in acne vulgaris: A randomized controlled trial. [2011.11]
BACKGROUND: Topical therapy with comedolytics and antibiotics are often advocated for mild and moderate severity acne vulgaris. Nadifloxacin, a new fluoroquinolone with anti-Propionibacterium acnes activity and additional anti-inflammatory activity, is approved for use in acne. This randomized controlled assessor blind trial compared the clinical effectiveness and safety of eight weeks therapy of nadifloxacin 1% versus clindamycin 1% as add-on therapy to benzoyl peroxide (2.5%) in mild to moderate grade acne... CONCLUSIONS: Topical nadifloxacin, a new fluoroquinolone is effective, tolerable, and safe for mild o moderate facial acne. Its clinical effectiveness is comparable to clindamycin when used as add-on therapy to benzoyl peroxide.

Efficacy of topical combination of benzoyl peroxide 5% and clindamycin 1% for the treatment of progressive macular hypomelanosis: a randomized, doubleblind, placebo-controlled trial. [2011.02]
BACKGROUND: Progressive macular hypomelanosis is a dermatosis without definite etiology. There is no consensus or first-line therapy in the treatment of progressive macular hypomelanosis, and the treatment options used are very little effective. OBJECTIVE: To evaluate the therapeutic efficacy of the topical combination of benzoyl peroxide 5% and clindamycin 1% associated with sun exposure for the treatment of progressive macular hypomelanosis... CONCLUSION: The topical combination of benzoyl peroxide 5% and clindamycin 1% is effective in the treatment of progressive macular hypomelanosis.

Topical clindamycin 1% vs. linoleic acid-rich phosphatidylcholine and nicotinamide 4% in the treatment of acne: a multicentre-randomized trial. [2011]
It has been shown that topical linoleic acid rich-phosphatidylcholine seems to be effective in normalization of follicular hyperkeratinization, whereas nicotinamide has an interesting anti-inflammatory effect. However, little is known about their combined effect on acne.Four percentage N-PHCL cosmetic treatment resulted slightly superior to topical clindamycin with all the parameters studied for its better compliance and the global clinical improvement.

Combination of azelaic acid 5% and clindamycin 2% for the treatment of acne vulgaris. [2011]
vulgaris... CONCLUSION: The profound reduction in lesion count and ASI by

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Clinical Trials Related to Clindagel (Clindamycin Topical)

A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne [Recruiting]
There are many different factors that cause acne. So combination treatment using different medications that can address these different factors is commonly used to treat acne. Fixed-dose combination clindamycin phosphate 1. 2% and tretinoin 0. 025% gel and benzoyl peroxide 6% foaming cloths are both used to treat acne. This study will evaluate the use of the medications when used together.

Dalacin-T Gel Post Approval Study [Completed]

Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria [Not yet recruiting]
Few efficient drugs for malaria treatment are available so far. Due to increased exposure of these drugs and due to the high risk of development of drug resistant strains of Plasmodium falciparum, new drug combinations have to be actively investigated. The investigators will test the efficiency, safety and tolerance of combined fosmidomycin and clindamycin treatment in acute uncomplicated malaria in children aged 3-10 years.

Fosmidomycin With Clindamycin or With Clindamycin Plus Artesunate [Not yet recruiting]
The aim of this study is to evaluate the role of clindamycin and artesunate as possible combination partners for fosmidomycin to protect it from its susceptibility to recrudescent infections when used as monotherapy for acute Plasmodium falciparum malaria while retaining its excellent safety profile

Safety and Efficacy Study of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel to Treat Rosacea [Recruiting]
The purpose of this study is to determine whether Clindamycin Phosphate 1. 2% And Tretinoin 0. 025% Gel are effective and safe in the treatment of papulopustular rosacea.

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