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)

Study Findings May Offer New Way To Kill Cancer Cells By Forcing Them Into An Alternative Programmed Death Pathway
Source: Cancer / Oncology News From Medical News Today [2013.05.16]
When cells suffer too much DNA damage, they are usually forced to undergo programmed cell death, or apoptosis. However, cancer cells often ignore these signals, flourishing even after chemotherapy drugs have ravaged their DNA...

The PiRNA Pathway Protects Eggs And Sperm From 'Jumping Genes' That Can Cause Developmental Defects, Sterility
Source: Fertility News From Medical News Today [2013.05.13]
Two teams of investigators led by Professor Gregory Hannon of Cold Spring Harbor Laboratory (CSHL) have published studies revealing many previously unknown components of an innate system that defends sex cells - the carriers of inheritance across generations - from the ravages of transposable genetic elements...

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Published Studies Related to Avage (Tazarotene)

Randomized comparison of the safety and efficacy of tazarotene 0.1% cream and adapalene 0.3% gel in the treatment of patients with at least moderate facial acne vulgaris. [2010.05]
This 16-week study evaluated once-daily tazarotene 0.1% cream and adapalene 0.3% gel in patients with moderate-to-severe acne. Patients treated with tazarotene 0.1% cream performed better in many acne efficacy measures (reduction in lesion counts, percentage of patients achieving a 50 percent lesion count reduction, overall disease severity, investigator's global assessment) than did patients treated with adapalene 0.3% gel...

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.

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Clinical Trials Related to Avage (Tazarotene)

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.

Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis [Recruiting]
The hypothesis of this study is that excimer (308-nm UVB) laser added to either tazarotene 0. 1% gel or acitretin 25 mg daily will lead to improved efficacy of these treatments alone.

The primary objective of this study is to compare the improvement of psoriatic plaques with and without excimer laser (308-nm UVB) treatment, applied in a randomized and blinded fashion, in subjects on acitretin 25 mg or tazarotene gel 0. 1% QD. The primary endpoint will be the comparison between the change in NPF score of plaques treated with excimer laser and those treated with sham treatment.

The secondary objectives are to compare the number of excimer light treatments and time necessary to achieve an average lesion assessment score of 0 to 1 in subjects treated with acitretin 25 mg PO or tazarotene gel 0. 1% QD, and to evaluate adverse events related to combinations of the study treatments.

Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Chest and Back [Recruiting]
RATIONALE: Drugs used in chemotherapy, such as tazarotene, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This randomized phase II trial is comparing two different schedules of topical tazarotene and topical placebo to see how well they work in treating patients with basal cell skin cancer and basal cell nevus syndrome on the chest.

Sorafenib-induced Hand- Foot Skin Reaction Treatment [Recruiting]

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

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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 44 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Hyperpigmentation
Dosage & duration:		Apply sparingly every other day (dosage frequency: every other day) for the period of 6 months
Other conditions:		brown spots, wrinkles
Other drugs taken:		40+ SPF Daily Sunscreen
		Reported Results
Benefits:		Moderate lightening of hyperpigmentation, smoothing of fine lines and wrinkles
Side effects:		Significant peeling of skin around nose and chin, very flakey and noticable, along with all over redness on cheeks, nose and chin.
Comments:		At night, applied pea size amount of cream after cleansing face. Significant peeling around the mouth and nose, so avoided these areas except 1x per week. Peeling would subside after skipping 1 to 2 days of treatment, so initially used 3x per week until skin became adapted to it. To minimize peeling, daily mild exfoliation of the skin really helped. While my hyperpigmentation is not completely gone, I am pleased with the tone of my skin and the minimized wrinkles.

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.