Currently Enrolling Trials
Renova contains the active ingredient tretinoin 0.02%, a vitamin A metabolite that occurs naturally in the body.
Renova is indicated as an adjunctive agent for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. Renova has not demonstrated a mitigating effect on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis.
Renova should be applied to the face once a day in the evening, using only enough to cover the entire affected area lightly. Patients should gently wash their faces with a mild soap, pat the skin dry, and wait 20 to 30 minutes before applying Renova. The patient should apply a small pearl-sized (about ¼ inch or 5 mm diameter) amount of cream to cover the entire affected area lightly. Caution should be taken when applying the cream to avoid the eyes, ears, nostrils, and mouth.
Application of Renova may cause a transitory feeling of warmth or slight stinging.
Mitigation (palliation) of fine facial wrinkling may occur gradually over the course of therapy. Up to 6 months of therapy may be required before the effects are seen.
With discontinuation of Renova therapy, some patients may lose the mitigating effects of Renova on fine facial wrinkles.
- Do NOT use Renova if the patient is pregnant or is attempting to become pregnant or is at high risk of pregnancy.
- Do NOT use Renova if the patient is sunburned or if the patient has eczema or other chronic skin conditions of the face.
- Do NOT use Renova if the patient is inherently sensitive to sunlight.
- Do NOT use Renova if the patient is also taking drug(s) known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.
Mechanism of Action
Tretinoin is an endogenous retinoid metabolite of Vitamin A that binds to intracellular receptors in the cytosol and nucleus, but cutaneous levels of tretinoin in excess of physiologic concentrations occur following application of a tretinoin-containing topical drug product. Although tretinoin activates three members of the retinoic acid (RAR) nuclear receptors (RARα, RARβ, and RARγ) which may act to modify gene expression, subsequent protein synthesis, and epithelial cell growth and differentiation, it has not been established whether the clinical effects of tretinoin are mediated through activation of retinoic acid receptors, other mechanisms such as irritation, or both.
Adverse effects associated with the use of Renova may include, but are not limited to, the following:
- dry skin
Clinical Trial Results
More than 300 subjects between the ages of 30 and 50 participated in the clinical studies of Renova, which were conducted during a 48-week period at eight research centers nationwide. Subjects received treatment for up to 48 weeks with Renova or a placebo, in conjunction with a comprehensive skin care and sun avoidance program.
In the clinical trials, physicians noted some signs of skin improvement in 78% of subjects treated with Renova. 64% of subjects showed improvement in fine wrinkling, 65% showed reduction in brown spots, and 51% showed smoothing of surface roughness. In subjects treated with a placebo skin cream plus a comprehensive skin care and sun avoidance program, 38% showed improvement in fine wrinkles, 48% showed reduction in brown spots, and 33% showed smoothing of surface roughness.