Nizoral Shampoo (Ketoconazole Shampoo) - Summary

SUMMARY

Nizoral® (ketoconazole) 2% Shampoo

NIZORAL® (ketoconazole) 2% Shampoo is a red-orange liquid for topical application, containing the broad spectrum synthetic antifungal agent ketoconazole in a concentration of 2% in an aqueous suspension.

NIZORAL® (ketoconazole) 2% Shampoo is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare).

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NEWS HIGHLIGHTS

Published Studies Related to Nizoral Shampoo (Ketoconazole Shampoo)

Clinical and mycological evaluation of therapeutic effectiveness of Solanum chrysotrichum standardized extract on patients with Pityriasis capitis (dandruff). A double blind and randomized clinical trial controlled with ketoconazole. [2004.06]
Dandruff (also called Pityriasis capitis) is a seborrhoeic dermatitis of the scalp. It has been correlated with the pathological colonization of the scalp with yeast from the genus Malassezia; this illness has a worldwide distribution and represents 25% of all scalp dermatosis cases... chrysotrichum on the local treatment of Pityriasis capitis associated with the yeast of the genus Malassezia.

A multicenter randomized trial of ketoconazole 2% and zinc pyrithione 1% shampoos in severe dandruff and seborrheic dermatitis. [2002.11]
Ketoconazole (KET) and zinc pyrithione (ZPT) are compounds active against the Malassezia spp. yeasts, which are believed to play a major role in dandruff and seborrheic dermatitis...

A randomised, single-blind, single-centre clinical trial to evaluate comparative clinical efficacy of shampoos containing ciclopirox olamine (1.5%) and salicylic acid (3%), or ketoconazole (2%, Nizoral) for the treatment of dandruff/seborrhoeic dermatitis. [2002.06]
BACKGROUND: The association between seborrhoeic dermatitis and dandruff and the yeast Malassezia furfur is well recognized. Symptoms include scalp itchiness and scaling. Due to its antimycotic activity, ciclopirox olamine is established as an effective treatment for these scalp conditions. Salicylic acid has keratolytic properties and aids in the removal of scales. OBJECTIVE: To compare the therapeutic efficacy of a shampoo containing 1.5% ciclopirox olamine and 3% salicylic acid (CPO/SA) with Nizoral (2.0% ketoconazole shampoo) in a study involving 154 subjects with dandruff - 70 of whom also had seborrhoeic dermatitis of the scalp. Nizoral is currently a registered treatment for dandruff and seborrhoeic dermatitis... CONCLUSION: The study demonstrated that both CPO/SA and Nizoral were safe and effective in the treatment of dandruff and seborrhoeic dermatitis.

Effect of ketoconazole 1% and 2% shampoos on severe dandruff and seborrhoeic dermatitis: clinical, squamometric and mycological assessments. [2001]
Ketoconazole (KET) is active to control dandruff and seborrhoeic dermatitis...

Ketoconazole 2% shampoo in the treatment of tinea versicolor: a multicenter, randomized, double-blind, placebo-controlled trial. [1998.12]
BACKGROUND: Tinea versicolor is a common superficial fungal infection caused by a lipophilic yeast. This chronically recurring opportunistic infection is especially prevalent in tropical and semitropical regions. The topical short-term application of ketoconazole 2% shampoo may provide effective and safe therapy for tinea versicolor. OBJECTIVE: The purpose of this study was to evaluate the efficacy and safety of a single application (1 day) versus three daily applications (3 days) of ketoconazole 2% shampoo versus placebo shampoo in the treatment of mycologically confirmed tinea versicolor... CONCLUSION: Ketoconazole 2% shampoo, used as a single application or daily for 3 days, is safe and highly effective in the treatment of tinea versicolor.

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Clinical Trials Related to Nizoral Shampoo (Ketoconazole Shampoo)

A Study to Assess the Safety and Interaction Between Casopitant and Ketoconazole When Taken By Healthy Adults [Completed]

Ixabepilone and Ketoconazole in Treating Patients With Advanced Solid Tumors [Active, not recruiting]
RATIONALE: Drugs used in chemotherapy, such as ixabepilone and ketoconazole, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving ixabepilone with ketoconazole may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of giving ixabepilone together with ketoconazole and to see how well they work in treating patients with advanced solid tumors.

Study Of Healthy Subjects To Assess The Effect Of Ketoconazole And The Way The Body Will React To Casopitant [GW679769] [Completed]
This is a two period study of healthy adult subjects to characterize the effect of the dosing of ketoconazole on the the way the body reacts to a dose of GW679769, and to assess the safety profile of oral casopitant with and without ketoconazole. This study will consist of a screening period, two treatment periods and a post-treatment follow-up visit.

Long Term Study of Extina in Patients With Seborrheic Dermatitis [Recruiting]
Open-label, multicenter, single-group study to assess the long-term safety of twice daily treatment with Extina (ketoconazole) Foam, 2% in subjects with seborrheic dermatitis.

Ketoconazole Foam 2% for the Treatment of Versicolor [Recruiting]
Objectives

1. To assess the efficacy of ketoconazole 2% foam for the treatment of tinea versicolor

2. To assess the safety of ketoconazole 2% foam for the treatment of tinea versicolor based on the occurrence of adverse events.

3. To assess treatment satisfaction as rated by patients

Study Design:

This will be a mono-centered, single arm, open-label pilot study. Ten adult patients age 19 and older with a clinical diagnosis of tinea versicolor, as well as a positive KOH using calcofluor, will be enrolled at the University of Alabama at Birmingham. There will be 4 scheduled visits (baseline, week 1, week 2, and week 4). A target area will be identified and mycological and clinical assessments will be performed at this site as well as a global assessment of each subject. Ketoconazole 2% foam will be applied to all affected areas for 2 weeks with a follow-up visit at week 4. Skin scraping using a disposable #15 blade for calcofluor/KOH assessment and photographs of target lesions will be performed at baseline, week 1, week 2, and week 4. Photographs will be taken at baseline and at week 4 (only if KOH is positive). Body surface area estimation of disease will also be performed at each visit. Evaluation of scale, hyperpigmentation/erythema, and hypopigmentation using a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) of the target area will be performed at baseline, week 1, week 2, and week 4. A global assessment will be conducted at each visit using the same 4 point scale. Patient questionnaires will be administered at baseline and week 2 to assess symptoms and satisfaction with study medication.

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PATIENT REVIEWS / RATINGS / COMMENTS

Nizoral Shampoo review by 25 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Dandruff
Dosage & duration:		2% (dosage frequency: twice a week) for the period of 2 weeks
Other conditions:		hair loss
Other drugs taken:		none
		Reported Results
Benefits:		Skin irritation and dandruff were eliminated after third use.
Side effects:		none
Comments:		Shampoo twice a week for at least three weeks. Apply on wet hair, massage with fingers and leave a product on the skin for about 5-10 minutes, then wash off with warm water. Do not use any conditioner after washing.