Avita (Tretinoin) - Summary

AVITA SUMMARY

AVITA® Cream, a topical retinoid, contains tretinoin 0.025% by weight in a hydrophilic cream vehicle of stearic acid, polyolprepolymer-2, isopropyl myristate, polyoxyl 40 stearate, propylene glycol, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water.

AVITA® Cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of this product in the treatment of other disorders have not been established.

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NEWS HIGHLIGHTS

Published Studies Related to Avita (Tretinoin)

Tretinoin cyclodextrin complex (RA/CyD) causes less irritation with an equal antiwrinkle effect compared with conventional tretinoin: clinical and histologic studies of photoaged skin. [2012]
the side effects compared with RA treatment alone... CONCLUSION: The findings show that RA and RA/CyD result in the equivalent

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%

A randomized, double-blind, controlled comparative trial of the anti-aging properties of non-prescription tri-retinol 1.1% vs. prescription tretinoin 0.025%. [2012]
Vitamin A and its derivatives (commonly termed retinoids) are widely used in topical anti-aging products. Certain retinoids such as retinol and its esters are available without a prescription, while others such as tretinoin are available only via prescription... Subjects reported >93 percent overall satisfaction with both products at weeks 8 and 12.

Further enhancement of facial appearance with a hydroquinone skin care system plus tretinoin in patients previously treated with botulinum toxin Type A. [2011.07]
BACKGROUND: A hydroquinone (HQ) skin care system has been designed for use in conjunction with nonsurgical procedures. OBJECTIVE: The authors evaluate the efficacy of this system plus tretinoin for improving facial appearance in comparison to a standard skin care regimen in users of botulinum toxin Type A (BoNT-A)... CONCLUSIONS: Adjunctive use of the HQ system plus tretinoin can further enhance the improvements in facial appearance attained with BoNT-A. Applying the HQ system plus tretinoin offers multiple clinical benefits over standard skin care, including significantly greater improvements in fine lines/wrinkles and hyperpigmentation.

Cortexolone 17alpha-propionate 1% cream, a new potent antiandrogen for topical treatment of acne vulgaris. A pilot randomized, double-blind comparative study vs. placebo and tretinoin 0.05% cream. [2011.07]
BACKGROUND: Acne vulgaris is a disorder of the pilosebaceous unit in which the androgens contribute to its onset and persistence. The use of antiandrogens is therefore potentially effective; however, antiandrogens for topical use are not available on the market. Cortexolone 17alpha-propionate (CB-03-01; Cosmo S.p.A, Lainate, Italy) is a new potent topical antiandrogen potentially useful in acne vulgaris. OBJECTIVES: To evaluate the safety and the topical efficacy of CB-03-01 1% cream in acne vulgaris as compared with placebo and with tretinoin 0.05% cream (Retin-A(R) ; Janssen-Cilag)... CONCLUSIONS: This pilot study supports the rationale for the use of topical antiandrogens in the treatment of acne vulgaris. CB-03-01 1% cream seems to fit with the profile of an ideal antiandrogen for topical use. (c) 2011 The Authors. BJD (c) 2011 British Association of Dermatologists 2011.

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Clinical Trials Related to Avita (Tretinoin)

Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy [Recruiting]
The purpose of this study is to find what effects, good and/or bad, treatment with two drugs has on leukemia. The first medicine is tretinoin (also called all-trans retinoic acid, ATRA, or Vesanoid). It is an approved medicine that causes the leukemia cells in APL to mature. It is related to vitamin A. The second is arsenic trioxide (Trisenox). It is an approved medicine for APL that comes back after earlier treatment.

APL is most often treated with tretinoin and standard chemotherapy drugs. These chemotherapy drugs can cause infection and bleeding. They can also damage the heart and normal bone marrow cells. This can lead to a second leukemia years later.

In this study, the investigators are using tretinoin and arsenic trioxide together. Both drugs work to treat APL. They have been used together in only a limited number of people. The investigators want to use these drugs together to reduce the amount of standard chemotherapy and decrease side effects. The patient will receive standard chemotherapy with a drug called idarubicin only if they have a higher chance of the leukemia coming back or a higher risk of side effects.

Comparison of Retinol 1.0% and Tretinoin 0.02% in the Treatment of Moderate to Severe Photodamage and Wrinkles [Recruiting]
The purpose of this study is to assess the comparative efficacy of retinol 1. 0% and tretinoin 0. 02% in minimizing wrinkles, discoloration, roughness, and other signs of moderate to severe photodamage. Our hypothesis is that both products will be of comparable benefit.

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.

A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin Emollient Cream, 0.05% for the Treatment of Photoaging [Recruiting]
The purpose of this study is to:

1. Evaluate the efficacy of Adapalene gel 0. 3% compared to Tretinoin Emollient cream 0. 05%, reducing signs of cutaneous photoageing, measured trough photonumeric scale evaluation, investigator evaluation of global response to treatment and subject's evaluation of improvement.

2. Evaluate the safety and tolerability of Adapalene Gel 0. 3%, compared to Tretinoin Emollient cream 0. 05% during 24 weeks of treatment.

The study has the clinical hypothesis that Adapalene Gel 0. 3% is as effective as Tretinoin Emollient cream 0. 05% in the treatment of cutaneous photoaging.

Atralin Gel for the Treatment of Rosacea [Recruiting]
Erythematotelangiectatic rosacea is a type of rosacea that causes a red face often with frequent flushing, topical sensitivity and prominent blood vessels. We think that long term damage to skin from the sun (photodamage) may play a role in causing this type of rosacea. Tretinoin is a topical medication that is known to improve photodamage. We want to find out if Atralin (tretinoin 0. 05%) Gel used for up to 46 weeks will improve erythematotelangiectatic rosacea (ETR).

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PATIENT REVIEWS / RATINGS / COMMENTS

Avita review by 46 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		HYPER PIGMENTATION, WRINKLES
Dosage & duration:		0.5% (dosage frequency: nightly) for the period of 2 months - ongoing
Other conditions:		asthma
Other drugs taken:		salbutamol
		Reported Results
Benefits:		After only three days of treatment my partner noticed a reduction in the hyperpigmentation, it took me about a month to notice these effects. Having used tretinoin now for two months the crepiness under my eyes is greatly reduced, there is undoubtedly a marked improvement in the texture of my skin and the hyperpigmentation is getting better every day.
Side effects:		Side effects were minor skin irritation especially in naso labial folds(itching, flaking and redness) and under eye area (slightly swollen on waking), however these symptoms were short lived and in the space of ten days disappeared altogether. There were a couple of occasions where i noticed small dry patches of skin which vanished in a couple of days.
Comments:		very simple really, wash and dry face at night, wait thirty minutes for face to dry completley, apply a pea sized amount of tretinoin avoiding corners of nose and eye lids.

Avita review by 23 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Acne
Dosage & duration:		.025% (dosage frequency: every night) for the period of 6 months
Other conditions:		sensitive skin
Other drugs taken:		none
		Reported Results
Benefits:		There was decrease in my acne and my skin became considerably smoother.
Side effects:		Luckily I did not notice many side effects. I only experienced occasional flaky skin and a very slight stinging sensation.
Comments:		I used Tretinoin every night after cleansing my face. After cleansing, I waited 15-20 minutes (as my doctor had recommended) and applied about a dime size of the medication on my entire face. I made sure to use a sunscreen in the morning because Tretinoin makes the skin sensitive to sunlight.

Avita review by 42 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		anti ageing
Dosage & duration:		daily (dosage frequency: twice a week) for the period of one month
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		Didn't really see any improvements but not sure if I am applying correct amount.
Side effects:		Some dry skin and flaking, which made make-up application difficult. Tried to exfoliate to which gave some improvement. Also, skin sensitivity after the initial peel of skin. Not sure if I will continue to use this product as I cannot see any improvement to fine lines.
Comments:		Daily application caused some irritation, so started to use is twice as week. Not sure if this is why I have seen little improvement.