Renova (Tretinoin) - Summary

RENOVA SUMMARY

RENOVA^®
(TRETINOIN EMOLLIENT CREAM)
0.05%

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.)

See all Renova indications & dosage >>

RENOVA NEWS HIGHLIGHTS

Media Articles Related to Renova (Tretinoin)

Louisiana Gov. Jindal's Plan For Medicaid Overhaul Similar To Republican Efforts For Medicare In 1995, Editorial States
Source: Medicare / Medicaid / SCHIP News From Medical News Today [2008.11.25]

isotretinoin, Accutane, Sotret, Claravis, Amnesteem
Source: MedicineNet Boils Specialty [2008.04.16]

more >>

Published Studies Related to Renova (Tretinoin)

A randomized controlled trial of the efficacy and safety of a fixed triple combination (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) compared with hydroquinone 4% cream in Asian patients with moderate to severe melasma. [2008.09]

A novel gel formulation of clindamycin phosphate-tretinoin is not associated with acne flaring. [2008.08]

A randomized controlled trial of the efficacy and safety of a fixed triple combination (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) compared with hydroquinone 4% cream in Asian patients with moderate to severe melasma. [2008.06.28]

Efficacy and safety of oral alitretinoin (9-cis retinoic acid) in patients with severe chronic hand eczema refractory to topical corticosteroids: results of a randomized, double-blind, placebo-controlled, multicentre trial. [2008.04]

Community-based trial results of combination clindamycin 1%--benzoyl peroxide 5% topical gel plus tretinoin microsphere gel 0.04% or 0.1% or adapalene gel 0.1% in the treatment of moderate to severe acne. [2007.07]

more >>

Clinical Trials Related to Renova (Tretinoin)

Decitabine and Tretinoin in Treating Patients With Myelodysplastic Syndromes [Recruiting]

Study to Compare the Acne Relapse Rate of Oral Minocycline to Oral Minocycline in Combination With Topical Tretinoin, Followed by Topical Tretinoin Alone [Recruiting]

Determine the Efficacy of Topical Tretinoin Cream for the Prevention of Nonmelanoma Skin Cancer [Active, not recruiting]

Tretinoin and Arsenic Trioxide With or Without Idarubicin in Treating Patients With Acute Promyelocytic Leukemia [Recruiting]

Phenylbutyrate and Tretinoin in Treating Patients With Hematologic Cancer [Completed]

more >>

RENOVA PATIENT REVIEWS / RATINGS / COMMENTS

Renova review by 61 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		hyperpigmentation
Dosage & duration:		.1% (dosage frequency: 1x every other night) for the period of 1 year
Other conditions:		facial wrinkles
Other drugs taken:		none
		Reported Results
Benefits:		Tretinoin, used in conjunction with the Obagi regimen, greatly reduced facial hyperpigmention which was due to hormones and sun damage.
Side effects:		Severe redness, burning and peeling occurred in the first 6-8 months of use, but gradually dissipated.
Comments:		Tretinoin (pea size) was blended on the back of the hand with an equal amount of Blender (#5 step in the Obagi system). The mixture was then applied to the face, neck and chest avoiding the eyes and lips. The residual cream remaining on the hand was spread on the back of the hands to reduce "age spots". No noticeable side effects were evident on the hands, but the procedure was effective. Care was taken not to expose the treated areas to sunlight.

Renova review by 50 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		wrinkles
Dosage & duration:		.05 (dosage frequency: nightly) for the period of 30 years
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		smoother skin,less lines on the face and neck area,collagen in skin is firmer and supple
Side effects:		mild flaking, skin can become red and senatize must wear 30 block suncreen
Comments:		wash face,wait 20 minutes then applied a pea size to dry skin always wear a good suncreen about thirthy percent. Make sure to apply every two hours

Renova review by 62 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		wrinkles
Dosage & duration:		5% (dosage frequency: every day) for the period of a week
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		none-i wanted to see some skin improvement of wrinkles but the side ffects of buning and redness were too severe to wait-not sure ahat else I can say here-i just discontinued the use-had to
Side effects:		burning and redness, had to stop using-it was therefore not effective for me-either my skin was too fragile or the product was just too strong for someone y age perhaps
Comments:		apply cream at night-that is what i was told-i had used it years ago when i was much younger and it was fine then-just not suitable for older more fragile skin i suppose