Tretinoin Hair and Skin Changes: What the Clinical Evidence Actually Shows

What the Renova label says tretinoin does to skin

Renova (tretinoin cream 0.02%) is indicated only as an adjunct to a comprehensive skin care and sunlight avoidance program, for mitigation (palliation) of fine facial wrinkles. The label states that it does not eliminate wrinkles, repair sun-damaged skin, reverse photoaging or restore more youthful skin, and that it has not demonstrated a mitigating effect on coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity or dermal elastosis [1]. Other tretinoin products, such as Retin-A and Retin-A Micro, are approved for acne vulgaris rather than wrinkles.

Five trials treated 324 evaluable patients with Renova and 332 with vehicle cream for 24 weeks; two of the five provided adequate demonstration of efficacy for fine facial wrinkling, and no two did so for coarse wrinkling, mottled hyperpigmentation, tactile roughness or laxity [1]. One single-center study of 107 darkly pigmented, mostly African-American patients with Fitzpatrick IV to VI skin found minimal or mild improvement in fine wrinkling in 43% of vehicle patients and 29% of Renova patients; the label says this finding may reflect the study's small size [1].

The label also says tretinoin activates RAR alpha, beta and gamma receptors, but that it has not been established whether the clinical effects work through receptor activation, other mechanisms such as irritation, or both [1].

Skin reactions, application and sun

In Renova's double-blind vehicle-controlled studies of 339 patients, almost all reported one or more local reactions such as peeling, dry skin, burning, stinging, erythema and pruritus; in 32% of all study patients irritation was severe, led to temporary discontinuation or led to a mild topical corticosteroid, and about 4% discontinued because of adverse reactions [1].

The Renova label directs once-daily evening application, using a pearl-sized amount (about 1/4 inch or 5 mm) after washing the face with mild soap and patting dry, and says to avoid the eyes, ears, nostrils and mouth. It also says larger amounts have not been shown to work faster and may cause marked redness, peeling or discomfort [1].

On sun, the Renova label says sunlight and sunlamp exposure should be avoided or minimized because of heightened sunburn susceptibility, that patients with sunburn should not use it until fully recovered, and that sunscreen (minimum SPF 15) and protective clothing should be used. It also says the product should not be given to patients taking photosensitizers such as thiazides, tetracyclines, fluoroquinolones, phenothiazines or sulfonamides [1].

Is there any evidence for hair?

The Renova label covers facial fine wrinkling and makes no claim about the scalp or hair [1]. Hair appears in the labeling only as a caution: the drug interactions section lists permanent wave solutions, electrolysis, hair depilatories or waxes, medicated or abrasive shampoos, alcohol-heavy products, astringents, and spices or lime as items to use with caution because they may increase irritation [1].

On absorption, the label says no percutaneous absorption study was done with Renova 0.02% in human volunteers; a study of a 0.05% oil-in-water cream in 7 healthy men found absorption of less than 2% of the applied dose after a single application and after 28 days of daily use [1]. The label calls oral tretinoin teratogenic in animals, while topical animal results are equivocal [1].

Pregnancy and product status

The Renova dosing section says not to use the product in patients who are pregnant, attempting to become pregnant or at high risk of pregnancy, and the pregnancy section says it should not be used during pregnancy [1]. The listed contraindication is sensitivity to any of its components [1]. Compounded tretinoin is not FDA-approved, and FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed [3]. HealthRX.com offers tretinoin by prescription.