Renova (Tretinoin) - Summary

RENOVA SUMMARY

RENOVA^®
(TRETINOIN CREAM)
0.02%

RENOVA (tretinoin emollient cream) 0.05% contains the active ingredient tretinoin (a retinoid) in an emollient cream base. Tretinoin is a yellow to light orange crystalline powder having a characteristic floral odor. Tretinoin is soluble in dimethylsulfoxide, slightly soluble in polyethylene glycol 400, octanol, and 100% ethanol. It is practically insoluble in water and mineral oil, and it is insoluble in glycerin. The chemical name for tretinoin is (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclonexen-1-yl)-2,4,6,8-nonatetraenoic acid.

RENOVA (tretinoin emollient cream) 0.05% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs alone (see bullet point 3 for populations in which effectiveness has not been established). RENOVA DOES NOT ELIMINATE WRINKLES, REPAIR SUN DAMAGED SKIN, REVERSE PHOTO-AGING, or RESTORE A MORE YOUTHFUL or YOUNGER DERMAL HISTOLOGIC PATTERN. Many patients achieve desired palliative effects on fine wrinkling, mottled hyperpigmentation, and tactile roughness of facial skin with the use of comprehensive skin care and sun avoidance programs including sunscreens, protective clothing, and emollient creams NOT containing tretinoin.

• RENOVA has demonstrated NO MITIGATING EFFECT on significant signs of chronic sun exposure such as coarse or deep wrinkling, skin yellowing, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis.
• RENOVA should only be used under medical supervision as an adjunct to a comprehensive skin care and sun avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing when desired results on fine wrinkles, mottled hyperpigmentation, and roughness of facial skin have not been achieved with a comprehensive skin care and sun avoidance program alone.
• The effectiveness of RENOVA in the mitigation of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin has not been established in people greater than 50 years of age OR in people with moderately to heavily pigmented skin. In addition, patients with visible actinic keratoses and patients with a history of skin cancer were excluded from clinical trials of RENOVA. Thus the effectiveness and safety of RENOVA in these populations are not known at this time.
• Neither the safety nor the effectiveness of RENOVA for the prevention or treatment of actinic keratoses or skin neoplasms has been established.
• Neither the safety nor the efficacy of using RENOVA daily for greater than 48 weeks has been established, and daily use beyond 48 weeks has not been systematically and histologically investigated in adequate and well-controlled trials. (See WARNINGS section.)

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NEWS HIGHLIGHTS

Media Articles Related to Renova (Tretinoin)

isotretinoin, Sotret, Claravis, Amnesteem, (Accutane is no longer available)
Source: MedicineNet Boils Specialty [2008.04.16]
Title: isotretinoin, Sotret, Claravis, Amnesteem, (Accutane is no longer available)
Category: Medications
Created: 12/31/1997
Last Editorial Review: 4/16/2008

Basilea's Toctino(R) Receives Marketing Authorization In Canada
Source: Dermatology News From Medical News Today [2009.11.18]
Basilea Pharmaceutica Ltd. announces that Toctino® (alitretinoin), a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids, has obtained regulatory approval from Health Canada. "We are delighted that Health Canada has approved the use of Toctino for patients with severe chronic hand eczema unresponsive to potent topical steroids.

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Published Studies Related to Renova (Tretinoin)

Tolerability of high-dose topical tretinoin: the Veterans Affairs Topical Tretinoin Chemoprevention Trial. [2009.10]
BACKGROUND: Topical tretinoin is a medication commonly used for acne that has potential application in the long-term treatment of photodamaged skin. However, there are few published data regarding the tolerability of high-dose tretinoin with long-term use. OBJECTIVES: To assess the long-term tolerability of tretinoin 0.1% cream... CONCLUSIONS: Overall, the tolerability level of topical tretinoin was high in this study population, with almost 40% of the tretinoin group reporting no side-effects, and the majority (67%) tolerating at least once-daily dosing at 6-month follow-up. High-dose topical tretinoin is feasible for long-term use in this population.

Benefits of using a hydroquinone/tretinoin skin care system in patients undergoing intense pulsed light therapy for photorejuvenation: a placebo-controlled study. [2009.09]
A hydroquinone/tretinoin (HQ/tret) skin care system designed for use with non-surgical facial rejuvenation procedures has recently become available. In this observer-masked study, 36 patients with moderate-to-severe wrinkling of the skin around the eyes and lips were randomly assigned to use either the 4% hydroquinone/0.05% tretinoin skin care system or placebo products, each day for 90 days...

Quality of life in the actinic neoplasia syndrome: The VA Topical Tretinoin Chemoprevention (VATTC) Trial. [2009.08]
BACKGROUND: Keratinocyte carcinomas (KCs) are the most common malignancies of the skin. As lesions have a low mortality rate, understanding quality-of-life (QoL) factors is necessary in their management. OBJECTIVE: To assess QoL and associated patient characteristics in those with a history of keratinocyte carcinomas... CONCLUSIONS: A history of ever use of 5-FU and present AKs was strongly associated with worse QoL. We find it more useful to consider these patients as having the chronic condition "actinic neoplasia syndrome," whose burden may be best measured by factors other than their history of KCs.

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.

Reappraising the phototoxicity of tretinoin: a report of four controlled clinical trials. [2009.06]
BACKGROUND: Retinoids are photoreactive molecules found in skin and retinal tissue. The use of retinoids in pharmacologic doses, applied topically, raises the potential of phototoxicities. Recent review articles and current US drug labeling indicate that tretinoin is a phototoxin. In developing a new formulation of topical all-trans-retinoic acid (tretinoin), formal testing of dermal photoreactions was therefore undertaken... CONCLUSION: The findings in these studies are consistent with previous studies of tretinoin in various formulations, and support the conclusion that tretinoin appears to be neither phototoxic nor photoallergenic in vivo.

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Clinical Trials Related to Renova (Tretinoin)

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.

Study to Compare the Acne Relapse Rate of Oral Minocycline to Oral Minocycline in Combination With Topical Tretinoin, Followed by Topical Tretinoin Alone [Recruiting]
The use of oral antibiotics alone to treat inflammatory acne provides little to no long term therapeutic benefit.

Acne relapse rates can be reduced by using topical tretinoin 0. 01% in conjunction with minocycline, thereby increasing the therapeutic effect of the oral antibiotic.

Determine the Efficacy of Topical Tretinoin Cream for the Prevention of Nonmelanoma Skin Cancer [Active, not recruiting]
One-third of all malignancies in the United States (approximately one million cases diagnosed annually) are nonmelanoma skin cancer (NMSC). NMSC causes considerable morbidity, economic burden, facial deformity and at least 1,000 deaths annually. Prevention of these malignancies with a topical agent free of serious side effects would confer substantial public health benefit. Three hundred fifty thousand veterans were expected to develop NMSC in 1994. NMSC is one of the most common conditions requiring dermatologic care in the VA system. Topical tretinoin has been used extensively to treat photoaged skin. Retinoids administered orally in high doses appear to be effective in chemoprevention of nonmelanoma skin cancer but have unacceptable toxicity. In this study, 1131 patients with a recent history of squamous cell and/or basal cell carcinoma were enrolled at six participating centers over a four-year period and were randomly assigned to either 0. 1% tretinoin cream or placebo. They were followed for a minimum of two years to determine if topical tretinoin is effective in reducing the risk of new occurrences.

Tretinoin and Arsenic Trioxide With or Without Idarubicin in Treating Patients With Acute Promyelocytic Leukemia [Recruiting]
RATIONALE: Tretinoin may help cancer cells become more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as arsenic trioxide and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving tretinoin together with arsenic trioxide with or without idarubicin may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving tretinoin together with arsenic trioxide with or without idarubicin works in treating patients with acute promyelocytic leukemia.

Phenylbutyrate and Tretinoin in Treating Patients With Hematologic Cancer [Completed]
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Tretinoin may help hematologic cancer cells develop into normal white blood cells.

PURPOSE: Phase I trial to study the effectiveness of combining phenylbutyrate and tretinoin in treating patients who have hematologic cancer.

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PATIENT REVIEWS / RATINGS / COMMENTS

Renova review by 24 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		acne
Dosage & duration:		.025 (dosage frequency: every now and then) for the period of 2 years
Other conditions:		none
Other drugs taken:		retin-A
		Reported Results
Benefits:		good for skin
Side effects:		none
Comments:		take alongside .05 retin-A treatment alternative, good stuff

Renova review by 55 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		wrinkles
Dosage & duration:		thin layer (dosage frequency: daily) for the period of six mos
Other conditions:		large pores
Other drugs taken:		HRT
		Reported Results
Benefits:		Some reduction in wrinkles and pores were observied, but I'm not sure if it's the Renova or the Fraxel or the combination.
Side effects:		Slight irritation at first with Renova. Fraxel treatments cause swelling and redness for a few days. Not too bad. But the Renova will sometimes cause skin to peel off and flake - looks bad but only lasts a day.
Comments:		I'm doing Fraxel treatements once every 4-6 wks, combined with Renova every night (except right after the Fraxel treatment). Some improvement has been observed.

Renova review by 52 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		anti aging
Dosage & duration:		.05 (dosage frequency: every day) for the period of two years
Other conditions:		wrinkles
Other drugs taken:		none
		Reported Results
Benefits:		At first, there was some minor improvement in the texture of my skin but then it began to degrade the area around my eye. The skin became thinner in appearance and more and more dry. It seemed to be harming my skin. At that point my dermotologist said my skin may be too sensitive. I do not feel that I have sensitive skin because while I may have a pale color skin, it has a olive tone. I do not sunburn very easily. Then I switched to ROC but had similar results.
Side effects:		Dry and thinning skin.
Comments:		I followed the directions which were to increase it gradually. Another drug that I have had success with is hydroquinone. It does bleach out my melasma very well but it takes perservance and regularity in its application.