Avage (Tazarotene) - Summary

AVAGE SUMMARY

AVAGE®
(TAZAROTENE) Cream, 0.1%

AVAGE® Cream is a white cream and contains the compound tazarotene; this formulation of tazarotene cream is also marketed for the treatment of plaque psoriasis and acne vulgaris as TAZORAC® (tazarotene) Cream, 0.1%.

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)

AVAGE® (TAZAROTENE) Cream 0.1% is indicated as an adjunctive agent for use in the mitigation (palliation) of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines in patients who use comprehensive skin care and sunlight avoidance programs. AVAGE® (TAZAROTENE) Cream 0.1% DOES NOT ELIMINATE or PREVENT WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN.

• AVAGE® (TAZAROTENE) Cream 0.1% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis.
• AVAGE® (TAZAROTENE) Cream 0.1% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing.
• Neither the safety nor the effectiveness of AVAGE® (TAZAROTENE) Cream 0.1% for the prevention or treatment of actinic keratoses, skin neoplasms, or lentigo maligna has been established.
• Neither the safety nor the efficacy of using AVAGE® (TAZAROTENE) Cream 0.1% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials. (See WARNINGS section.)

NEWS HIGHLIGHTS

Media Articles Related to Avage (Tazarotene)

Cleavage Rejuvenation, Do-It-Yourself Lasers, Botox® Breast Lift - Hype Or Reality?
Source: Cosmetic Medicine / Plastic Surgery News From Medical News Today [2009.10.26]
Whether their effectiveness is fact or fiction, less invasive cosmetic procedures such as cleavage rejuvenation, do-it-yourself (DIY) cosmetic therapies, and using Botox® to "lift" the breasts are making headlines, but are they safe? Plastic surgeons are discussing if these, and more, are cutting edge new discoveries or just "buyer beware" marketing hype at the American Society of Plastic Surgeons (ASPS) Plastic Surgery 2009 conference, Oct. 23 - 27, in Seattle.

Sick And Vulnerable Australians Hit Hard By Government Health Cuts
Source: Eye Health / Blindness News From Medical News Today [2009.11.03]
AMA President, Dr Andrew Pesce, said the human cost of the Government's savage cuts to Medicare patient rebates for critical medical procedures is becoming more evident as people with eye, heart and joint conditions become aware that they must pay more for their treatment.

Dendritic Cells Spark Smoldering Inflammation In Smokers' Lungs
Source: Smoking / Quit Smoking News From Medical News Today [2009.10.29]
Inflammation still ravages the lungs of some smokers years after they quit the habit. What sparks that smoldering destruction remained a mystery until a consortium of researchers led by Baylor College of Medicine found that certain dendritic cells in the lung - the cells that "present" a foreign antigen or protein to the immune system - provoke production of destructive T-cells that attack a key protein called elastin, leading to death of lung tissue and emphysema.

Plastic Surgeons Should Be Part Of Disaster Relief Planning, Response
Source: Bio-terrorism / Terrorism News From Medical News Today [2009.09.12]
When a terrorist bomb explodes, a tornado rips through a town, a hurricane devastates a region, or wildfires ravage homes and businesses, plastic surgeons are not typically atop the list of emergency responders. But they should be, UT Southwestern Medical Center plastic surgeons and disaster experts recommend in the September issue of Plastic and Reconstructive Surgery.

UA Researchers Seek Safer Cystic Fibrosis Test
Source: Cystic Fibrosis News From Medical News Today [2009.09.11]
Researchers from The University of Arizona Colleges of Pharmacy and Medicine are teaming up to try to invent a novel non-invasive lung test for cystic fibrosis sufferers. Eric Snyder, PhD, assistant professor at the UA College of Pharmacy, is the principal investigator on the study, "Quantification of Exhaled Condensate Using Bronchoalveolar Lavage in Cystic Fibrosis." Dr.

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Published Studies Related to Avage (Tazarotene)

Comparative efficacy and safety results of two topical combination acne regimens. [2009.07]
Combination therapy has become the standard for the management of acne, particularly for moderate-to-severe cases... Both treatment regimens were well-tolerated.

Randomized double-blind trial of prophylactic oral minocycline and topical tazarotene for cetuximab-associated acne-like eruption. [2007.12.01]
PURPOSE: To evaluate the ability of either oral minocycline, topical tazarotene or both, to reduce or prevent cetuximab-related acneiform rash when administered starting on day 1 of cetuximab therapy... CONCLUSION: Prophylaxis with oral minocycline may be useful in decreasing the severity of the acneiform rash during the first month of cetuximab treatment. Topical tazarotene is not recommended for management of cetuximab-related rash.

Tazarotene 0.1 percent cream plus clindamycin 1 percent gel versus tretinoin 0.025 percent gel plus clindamycin 1 percent gel in the treatment of facial acne vulgaris. [2007.07.13]
Topical retinoids are the cornerstone of therapy for acne vulgaris...

Tolerability comparison of adapalene gel, 0.3% versus tazarotene cream, 0.05% in subjects with healthy skin. [2007.06]
BACKGROUND: Topical retinoids, including adapalene and tazarotene, are a primary treatment choice for patients with acne. Adapalene is currently marketed in a 0.1% concentration in gel and cream formulation. A new gel containing a higher concentration (0.3%) of adapalene has been developed. In clinical studies, adapalene 0.1% concentration has proven to be better tolerated than other retinoids in skin treatment. However, the tolerability of adapalene gel 0.3% has yet to be compared to other topical retinoids. PURPOSE: The purpose of this study was to compare the local cutaneous tolerability of adapalene gel 0.3% once daily versus tazarotene cream 0.05% once daily... CONCLUSION: Adapalene gel 0.3% is very well-tolerated with good cosmetic acceptability.

Comparison of clinical efficacy of topical tazarotene 0.1% cream with topical clobetasol propionate 0.05% cream in chronic plaque psoriasis: a double-blind, randomized, right-left comparison study. [2007.01]
BACKGROUND: No controlled data is available till date comparing topical tazarotene and clobetasol in Indian psoriatic patients. OBJECTIVE: The aim was to compare the clinical efficacy of 12 weeks of once-daily tazarotene 0.1% cream with that of once-daily clobetasol propionate 0.05% cream in the treatment of patients with chronic plaque psoriasis... CONCLUSION: Topical tazarotene 0.1% cream is less effective than topical clobetasol propionate 0.05% cream in the treatment of plaque psoriasis. It has more effect on induration than on erythema and scaling of psoriatic lesions.

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Clinical Trials Related to Avage (Tazarotene)

Comparison of Tazarotene and Minocycline Therapies for Maintenance of Facial Acne Vulgaris [Completed]

Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne [Recruiting]
Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris.

You may be suitable to take part in this study because you have acne vulgaris on your face. Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms, legs, and back.

Dapsone Gel 5% and Tazarotene Cream 0.1% Versus Tazarotene Cream 0.1% Monotherapy for Facial Acne Vulgaris [Recruiting]
A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tazarotene cream 0. 1% compared with tazarotene cream 0. 1% monotherapy in treating moderate to severe facial acne vulgaris

Decitabine and Tretinoin in Treating Patients With Myelodysplastic Syndromes [Recruiting]
RATIONALE: Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of myelodysplastic cells, either by killing the cells or by stopping them from dividing. Tretinoin and decitabine may help myelodysplastic cells become more like normal cells, and to grow and spread more slowly. Giving decitabine together with tretinoin may be an effective treatment for myelodysplastic syndromes.

PURPOSE: This phase I/II trial is studying the side effects and best dose of tretinoin when given together with decitabine in treating patients with myelodysplastic syndromes.

Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study [Recruiting]
This is an open label, prospective study to evaluate therapeutic potential of Tazarotene 0. 1% cream for the treatment of Stage I-IIA CTCL. Patients with Stage I-IIA disease are enrolled into the study. Tazarotene will be used for up to 24 weeks and patients will be followed for up to 12 months.

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PATIENT REVIEWS / RATINGS / COMMENTS

Avage review by 42 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Hormonal Acne/Sun Damage
Dosage & duration:		Apply to affected area once daily (dosage frequency: once daily) for the period of 7 months
Other conditions:		n/a
Other drugs taken:		n/a
		Reported Results
Benefits:		Skin is clear smooth and brite. Best it has looked in years
Side effects:		initial breakouts worsen, peeling, dryness, redness, burning for the first few weeks and then got better.
Comments:		The first few weeks were horrible with bad break outs, dryness, burning, redness, Peeling, It was a nightmare. Almost gave up on it but my dr would not let me. I then started using a moisteriser right after washing my face and then waited 1/2 hour to 1 hour before the Taz. Symptoms eased up and now my skin is beautiful. This stuff Rocks. Don't give up and keep it off of your lips!

Avage review by 45 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		dark spots
Dosage & duration:		once a day (dosage frequency: once a day) for the period of one year
Other conditions:		Dark freckles probably associated with pregnancy.
Other drugs taken:		none
		Reported Results
Benefits:		I didn't notice dramatic results with this product and it was fairly expensive at $100 for one tube. I wasn't religious about applying it each day, so that might have had an impact on the effectiveness. I didn't notice significant fading of the darkest large freckles on my face as I had hoped. I didn't notice any significant reduction in wrinkles.
Side effects:		I did not experience any burning sensations with this product in the first week or there after. The product did make my face peel significantly the following day and this occured even with the use of an exfoliating facial wash each morning.
Comments:		I applied the product to my face in the morning OR evening and did it in combination with other typical facial sunscreen products and mosterizers. Since the product was expensive and made my face peel, I tended to apply it only on the dark freckles I was trying to fade.

Avage review by 45 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		dark spots
Dosage & duration:		once a day (dosage frequency: once a day) for the period of one year
Other conditions:		Dark freckles probably associated with pregnancy.
Other drugs taken:		none
		Reported Results
Benefits:		I didn't notice dramatic results with this product and it was fairly expensive at $100 for one tube. I wasn't religious about applying it each day, so that might have had an impact on the effectiveness. I didn't notice significant fading of the darkest large freckles on my face as I had hoped. I didn't notice any significant reduction in wrinkles.
Side effects:		I did not experience any burning sensations with this product in the first week or there after. The product did make my face peel significantly the following day and this occured even with the use of an exfoliating facial wash each morning.
Comments:		I applied the product to my face in the morning OR evening and did it in combination with other typical facial sunscreen products and mosterizers. Since the product was expensive and made my face peel, I tended to apply it only on the dark freckles I was trying to fade.