Tretinoin for wrinkles: what the label says

Tretinoin can reduce fine facial wrinkles for some people, and it does not remove them. One tretinoin cream, Renova 0.02 percent, has an FDA-reviewed label for fine facial wrinkles, and that label states in capital letters that the cream "DOES NOT ELIMINATE WRINKLES". This guide reports the label's limits next to the trial results. For the drug itself, see the tretinoin guide.

Skinli gives general education and is not a doctor. Tretinoin is a prescription drug, and your prescriber picks the product, the strength and the schedule. For the studies below, Skinli read the published summaries (abstracts) only.

What tretinoin is approved to do for wrinkles

MedlinePlus, the National Library of Medicine's patient site, lists two uses: "Tretinoin is used to treat acne. Tretinoin is also used to reduce fine wrinkles." Further down the page it gives the limit: "Tretinoin may reduce fine wrinkles but does not remove them or repair sun-damaged skin."

The wrinkle product on DailyMed, the same library's database of drug labels, is Renova cream 0.02 percent. Its label says the cream is "for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs." Mitigation and palliation both mean making a problem less severe. The program in the trials was "sunscreens, protective clothing, and non-prescription emollient creams", which are plain moisturizing creams.

The tretinoin products for acne carry a different label. The generic cream label covers acne and adds: "The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established." A prescriber may still choose a product for a use its label does not list.

Tretinoin is a drug, and the FDA says drugs "must have FDA approval for both safety and effectiveness before they go on the market." A cosmetic wrinkle cream from a store has no such step. The guide to retinol vs retinoid explains how store retinol differs from tretinoin.

What the Renova trials found

The label reports five trials that lasted 24 weeks. Four enrolled people with lighter skin, and one enrolled people with darker skin. Everyone followed the sun and skin care program. One group also used Renova, and the other used the same cream with no drug in it, which the label calls the vehicle.

Fine wrinkles after 24 weeks, lighter skin	Renova 0.02 percent (279 people)	Cream with no drug (280 people)
Worse	1 percent	3 percent
No change	40 percent	58 percent
Minimal improvement	35 percent	27 percent
Mild improvement	15 percent	9 percent
Moderate improvement	10 percent	3 percent

Adding the three improvement rows gives 60 percent of people on Renova and 39 percent on the cream with no drug. Most of the improvement on Renova was minimal or mild.

The label says of the comparison group: "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". Sun protection and moisturizer improved fine wrinkles in both groups.

The label also reports its weaker results. "Two of the five trials provided adequate demonstration of efficacy for mitigation of fine facial wrinkling." The one trial in people with darker skin had 107 people, and more of them improved without the drug. The label reports "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*." CSP is the sun and skin care program. The label adds that "these findings may reflect the small size of this study."

What the label says tretinoin does not do

The Renova label lists its limits in capital letters:

• The cream "DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN." Photoaging means the skin changes caused by years of sun.
• It "has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation". In plain words, the trials showed no effect on deep wrinkles, rough skin or blotchy dark patches.
• No two of the five trials showed an effect on laxity, which means loose skin.
• The patient leaflet says the cream "does not work for everyone who uses it."

The American Academy of Dermatology (AAD) says tretinoin "reduces fine lines and wrinkles", and it sets a modest expectation for every skin product sold for aging: "anti-aging skin care products deliver modest results. You cannot get the results of a facelift from a cream."

What other trials of tretinoin cream found

Several trials tested tretinoin creams on sun-damaged facial skin. Most used a stronger cream than Renova 0.02 percent.

Study	People and length	Cream	Result
JAMA, 1988	30 people, 16 weeks	Strength not given in the abstract	14 of the 15 people who used tretinoin on the face improved. None of those on the cream with no drug improved
Journal of the American Academy of Dermatology, 1992	296 people, 24 weeks	0.05, 0.01 and 0.001 percent	68 percent improved on 0.05 percent, against 43 percent on the cream with no drug. The two lower strengths showed no significant difference from the cream with no drug
Australasian Journal of Dermatology, 1994	125 people, 24 weeks	0.05 percent	People on tretinoin reported improvements in "skin wrinkles, tightness, colour and pores"
Archives of Dermatology, 1995	99 people, 48 weeks	0.1 and 0.025 percent	Both strengths improved sun-damaged skin by a similar amount. Redness and scaling were greater at 0.1 percent
American Journal of Clinical Dermatology, 2005	204 people, up to 2 years	0.05 percent	More improvement than the cream with no drug in fine and coarse wrinkling and in blotchy color
International Journal of Women's Dermatology, 2022	A review of 7 trials	0.025 percent and higher	Every trial reported improvement in wrinkling, seen "as early as 1 month"

Two limits apply to this table. The 2022 review says the trials used different tretinoin formulas and different ways of measuring results. The abstracts of the 1992 and 2005 trials show no funding line, so who paid for them is unknown here.

Coarse wrinkling improved with the 0.05 percent cream in the 2005 trial, and the trials of Renova 0.02 percent showed no effect on it.

None of these sources publishes photos. For before and after results, the numbers above are what exists, and tretinoin before and after explains how to read trial numbers.

Which strength is best for wrinkles

No source read for this guide names one best strength. In the 48-week trial of 99 people, the authors wrote that "there were no clinically or statistically significant differences in efficacy between the two concentrations of tretinoin", 0.1 and 0.025 percent. Efficacy means how well a drug works. The 0.1 percent cream caused more redness and scaling. In the 24-week trial of 296 people, 0.05 percent did better than the cream with no drug and 0.01 percent did no better. The Renova label says no study has compared its 0.02 percent cream with the older 0.05 percent cream.

The strength is your prescriber's decision, and MedlinePlus says to use tretinoin only as often and in the amount your doctor prescribes.

How long it takes and how long it lasts

Source	Time to see a change in wrinkles
Renova label	"Up to 6 months of therapy may be required before the effects are seen."
Renova patient leaflet	"Generally, you may notice some effects in 3 to 4 months."
MedlinePlus	"It may take 3 to 4 months or up to 6 months before you notice improvement."
2022 review of 7 trials	Changes "as early as 1 month"

Acne follows a different timeline, covered in how long tretinoin takes to work.

The improvement depends on continued use. The Renova label says: "Patients may lose some of the mitigating effects of RENOVA (tretinoin cream) 0.02% after 12 weeks of discontinuation". MedlinePlus says: "If you stop using tretinoin, the improvement may gradually disappear." One trial followed 126 people who had finished 48 weeks of daily 0.05 percent cream. Over the next 24 weeks the improvement "was sustained with three-times weekly applications and to a lesser extent with once-weekly dosing, whereas effects tended to regress in subjects off therapy."

Long use has limits too. The label says: "Neither the safety nor the efficacy of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 weeks has been established". It also reports unusual changes in skin cells, seen under a microscope, in some patients who used the older 0.05 percent cream for longer than 48 weeks, and says their meaning is unknown. The two-year trial of 204 people found "no increase" in such changes compared with the cream with no drug. See what happens if you stop tretinoin.

Side effects and the sun rules on the wrinkle label

Irritation was common in the Renova trials. The label says: "Almost all patients reported one or more local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus." Erythema means redness and pruritus means itching. In 32 percent of patients the irritation was severe, led to a pause, or led to a mild steroid cream for a short time. See tretinoin side effects.

The label asks for sun protection and moisturizer with the cream, and sets other limits:

• Sunscreen. "Patients should be warned to use sunscreens (minimum SPF of 15) and protective clothing". The AAD's wrinkle page asks for more, a sunscreen or moisturizer with "an SPF of at least 30". See sunscreen with tretinoin.
• Moisturizer. The leaflet says: "Skin moisturizers should be used at least every morning to protect the treated areas from dryness."
• Where it goes. The label says "It is for use on the face." and tells patients to keep the cream away from the eyes, ears, nostrils and mouth. See tretinoin under the eyes.
• Age. "Safety and effectiveness in patients less than 18 years of age have not been established." The label says the same for people older than 71.
• Pregnancy. The leaflet says not to use Renova if you are pregnant or trying to become pregnant. The guide to retinoids during pregnancy and breastfeeding has the detail.

When to see a doctor

Tretinoin for wrinkles needs a prescriber. The Renova label says the cream "should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program". The guide on how to get tretinoin explains the prescription step.

Tell the prescriber about your skin history. MedlinePlus says to mention eczema, skin cancer, and "actinic keratoses (scaly spots or patches on the top layer of the skin)". The Renova trials left out people with those scaly spots and people with a history of skin cancer, so the label says its safety in those groups is unknown. For deep wrinkles and dark patches, where the Renova trials showed no effect, a dermatologist can explain other treatments.

Stop the cream and call your prescriber if the irritation is severe or does not ease, if the skin blisters or swells, or if you get sunburned. See a doctor about any scaly spot or any spot that changes. The Renova label says its safety and effectiveness for treating such spots or skin tumors have not been established.