INDICATIONS AND USAGE
(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)
RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blinded, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams.
RENOVA (tretinoin cream) 0.02% 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 (tretinoin cream) 0.02% 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.
Patients with visible actinic keratoses and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA (tretinoin cream) 0.02% in these populations are not known at this time.
Neither the safety nor the effectiveness of RENOVA (tretinoin cream) 0.02% for the prevention or treatment of actinic keratoses or skin neoplasms has been established.
Neither the safety nor the efficacy of RENOVA (tretinoin cream) 0.02% 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.)
CLINICAL TRIALS
Four adequate and well-controlled multi-center trials and one single-center randomized, controlled trial were conducted involving a total of 324 evaluable patients treated with RENOVA (tretinoin cream) 0.02% and 332 evaluable patients treated with the vehicle cream on the face for 24 weeks with a comprehensive skin care and sun avoidance program, to assess the effects on fine and coarse wrinkling, mottled hyperpigmentation, tactile skin roughness, and laxity. Patients were evaluated at baseline on a 10 unit scale and changes from the baseline rating were categorized as follows:
Worsening:
Increase of 1 unit or more.
No improvement:
No change.
Minimal improvement:
Reduction of 1 unit.
Mild improvement:
Reduction of 2 units.
Moderate improvement:
Reduction of 3 units or more.
In these trials, the fine and coarse wrinkling, mottled hyperpigmentation, tactile roughness, and laxity of the facial skin were thought to be caused by multiple factors which included intrinsic aging or environmental factors, such as chronic sunlight exposure.
Two of the five trials provided adequate demonstration of efficacy for mitigation of fine facial wrinkling. No two of the five trials adequately demonstrated efficacy for mitigation of coarse wrinkling, mottled hyperpigmentation, tactile skin roughness, and laxity. Data for fine wrinkling (the indication for which RENOVA (tretinoin cream) 0.02% demonstrated efficacy) from all five trials (four studies in lightly pigmented subjects with Fitzpatrick Skin Types I-III and one study in darkly pigmented subjects with Fitzpatrick Skin Types IV-VI) is provided below:
FINE WRINKLING IN LIGHTLY PIGMENTED SUBJECTS
Subjects using RENOVA (tretinoin cream) 0.02% + CSPCSP = Comprehensive skin protection and sunlight avoidance programs including use of sunscreens, protective clothing, and non-prescription emollient creams. (N=279)
Vehicle + CSP (N=280)
A single-center study (N=107) in darkly pigmented, mostly African-American, subjects with Fitzpatrick Skin Types IV-VI demonstrated minimal or mild improvement in fine facial wrinkling in 43% of patients using Vehicle + CSP compared to 29% of subjects using RENOVA (tretinoin cream) 0.02% + CSP. Although fewer darkly pigmented subjects improved with RENOVA (tretinoin cream) 0.02% than with vehicle, these findings may reflect the small size of this study.
Worsened
1%
3%
No Change
40%
58%
Minimal Improvement
35%
27%
Mild Improvement
15%
9%
Moderate Improvement
10%
3%
Self-assessment of fine wrinkles after 24 weeks of treatment with either RENOVA (tretinoin cream) 0.02% or Vehicle from the four studies in lightly pigmented patients showed the following:
No studies have been conducted comparing the facial irritation or efficacy of RENOVA (tretinoin cream) 0.02% to RENOVA (tretinoin cream) 0.05% (older marketed formulation).
Patients may lose some of the mitigating effects of RENOVA (tretinoin cream) 0.02% after 12 weeks of discontinuation of RENOVA (tretinoin cream) 0.02% from their comprehensive skin care and sunlight avoidance program.
Figure