Renova (Tretinoin) - Summary

RENOVA SUMMARY

RENOVA^® (tretinoin cream) 0.02% contains the active ingredient tretinoin in a 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-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is also referred to as all-trans-retinoic acid and has a molecular weight of 300.44.

(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% + CSP 1 (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%

¹ CSP = Comprehensive skin protection and sunlight avoidance programs including use of sunscreens, protective clothing, and non-prescription emollient creams.

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.

See all Renova indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Renova (Tretinoin)

Effect of Aloe vera topical gel combined with tretinoin in treatment of mild and moderate acne vulgaris: a randomized, double-blind, prospective trial. [2014]
CONCLUSION: The combination TR/AVG was well tolerated and significantly more

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.

more studies >>

Clinical Trials Related to Renova (Tretinoin)

Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' for Patients With Erectile Dysfunction [Completed]
This is a prospective, randomized, double-blind clinical study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.

Safety and Efficacy Associated With Treating Erectile Dysfunction Patients With Low Intensity Shockwaves by Renova [Terminated]
This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with the Low Intensity Extracorporeal Shockwave Therapy

(LI-ESWT) device - "Renova" on symptomatic ED patients to the safety and efficacy of the

control sham patients.

Low Intensity Extracorporeal Shockwave Therapy for Patients With Erectile Dysfunction [Completed]
This is a prospective, pilot study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.

Linear Focused Shockwave Treatment for Erectile Dysfunction [Recruiting]
The study is aimed at comparing the performance of protocols employing one and two sessions per week, respectively. The study hypothesis claims that there is no significant difference between the performances of the compared protocols.

Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia [Recruiting]
This phase III trial studies tretinoin and arsenic trioxide in treating patients with newly diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia involves high doses of a common class of chemotherapy drugs called anthracyclines, which are known to cause long-term side effects, especially to the heart. Tretinoin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may stop the growth of cancer cells by either killing the cells, by stopping them from dividing, or by stopping them from spreading. Completely removing or reducing the amount of anthracycline chemotherapy and giving tretinoin together with arsenic trioxide may be an effective treatment for acute promyelocytic leukemia and may reduce some of the long-term side effects.

more trials >>

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 43 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		melasma
Dosage & duration:		0.025% (dosage frequency: once per day) for the period of 4 weeks
Other conditions:		wrinkles
Other drugs taken:		Hydroquinone
		Reported Results
Benefits:		Faint pigmentation started to disappear after ten days of use, and dark ones continued to become lighter. Overall, skin became smoother and lighter after cleansing.
Side effects:		Sever redness and scaling occurred especially around the chin and the cheek, which could not be covered with makeup. Mild itching sensation was a little disturbing to focus at work.
Comments:		Applied at night, after cleansing the face, more than thirty minutes before going to bed. Used ~1 cm of the cream for entire face and neck, followed with 4% Hydroquinone solution. When swelling occurred, application was omitted until it disappears, which usually took place in 24 hours.

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.