Tretinoin Non-Responder Profile: Why It Doesn't Work for Everyone

What does the Renova label show about response?

Renova 0.02% cream is indicated only as an adjunct, with a comprehensive skin care and sunlight avoidance program, for mitigation of fine facial wrinkles. The label states it does not eliminate wrinkles, repair sun-damaged skin, reverse photoaging, or restore more youthful or younger skin [1].

Four multicenter trials and one single-center trial enrolled 324 evaluable patients treated with Renova and 332 treated with vehicle for 24 weeks [1]. Two of the five trials provided adequate demonstration of efficacy for fine facial wrinkling; no two of the five adequately demonstrated efficacy for coarse wrinkling, mottled hyperpigmentation, tactile roughness, or laxity [1].

In the fine-wrinkle table for lightly pigmented subjects, 40% of Renova users had no change versus 58% of vehicle users; 1% worsened versus 3%; minimal improvement was 35% versus 27%; mild improvement 15% versus 9%; moderate improvement 10% versus 3% [1].

The label table reports group percentages, not individual responder status [1].

How common is irritation with Renova?

In the Renova studies involving 339 patients who applied Renova 0.02% to their faces, almost all reported one or more local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus [1].

32% had skin irritation that was severe, led to temporary discontinuation, or led to use of a mild topical corticosteroid. About 7% of Renova users, compared with less than 1% of control patients, had sufficiently severe local irritation to warrant short-term use of mild topical corticosteroids. About 4% discontinued because of adverse reactions [1].

The label calls Renova a dermal irritant and says if the degree of local irritation warrants, patients should be directed to use less medication, decrease frequency, discontinue temporarily, or discontinue altogether and consider additional appropriate therapy [1].

How long are the studies, and does more product help?

The Renova trials ran 24 weeks [1]. The label says neither the safety nor efficacy of using Renova 0.02% daily for greater than 52 weeks has been established [1].

The label says application of larger amounts of medication than recommended has not been shown to lead to more rapid or better results, and marked redness, peeling, or discomfort may occur [1]. It also says no studies have been conducted comparing the facial irritation or efficacy of Renova 0.02% with the older 0.05% formulation [1].

What skin-type data does the label report?

The label reports a single-center study of 107 darkly pigmented, mostly African-American subjects with Fitzpatrick skin types IV to VI. Minimal or mild improvement in fine facial wrinkling occurred in 43% of vehicle users compared with 29% of Renova users. The label says these findings may reflect the small size of this study [1].

Who should not use Renova according to the label?

The Renova label says it should not be used during pregnancy, including if the patient is attempting to become pregnant or is at high risk of pregnancy, or if the patient is also taking drugs known to be photosensitizers, such as thiazides, tetracyclines, fluoroquinolones, phenothiazines, or sulfonamides, because of possible augmented phototoxicity. Patients with sunburn should not use it until fully recovered [1].

Patients who are inherently sensitive to sunlight, or who have considerable sun exposure, should use caution, as should patients with eczema or other chronic skin conditions of the face [1].

The label also says to keep it out of the eyes, mouth, angles of the nose, and mucous membranes. Topical use may cause severe local erythema, pruritus, burning, stinging, and peeling at the site of application [1].

What sun precautions does the label require?

The label says exposure to sunlight, including sunlamps, should be avoided or minimized because of heightened sunburn susceptibility; patients should use sunscreens with a minimum SPF of 15 and protective clothing; patients with sunburn should not use Renova until fully recovered; and those with considerable sun exposure or inherent sun sensitivity should exercise caution [1].

Is compounded tretinoin the same?

Compounded tretinoin is not FDA-approved, and FDA does not verify the safety, effectiveness, or quality of compounded drugs before they are marketed [2]. Renova 0.02% cream is an FDA-approved prescription product [1].