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Tretinoin Year-1 Outcomes: What Real Users Actually Experience

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At a glance

  • Drug / tretinoin topical, a prescription retinoid [2]
  • Labeled use (Renova 0.02% cream) / adjunct for fine facial wrinkles with skin care and sun avoidance [2]
  • 12-week acne result / tretinoin 0.025% gel: 37% mean reduction in total lesions [4]
  • 24-week photodamage result / 79% overall improvement with 0.05% vs 48% with vehicle [5]
  • 40-week pigment result / facial post-inflammatory marks lighter with 0.1% tretinoin than with vehicle [3]
  • 10 to 12 month biopsy result / collagen I formation up 80% vs down 14% on vehicle [1]

What does year-one evidence look like?

The evidence is fixed-timepoint rather than month by month: 12-week acne trials, 24- and 40-week studies, and biopsies after 10 to 12 months of use [6][1][5][3][4].

What the trials measured

In a 12-week multicenter trial that compared tretinoin 0.025% gel with adapalene 0.1% gel, tretinoin reduced total lesion counts by 37%, non-inflammatory lesions by 33%, and inflammatory lesions by 38% [4].

A double-blind, vehicle-controlled study of 251 subjects with mild to moderate photodamaged facial skin found 79% overall improvement after 24 weeks of tretinoin 0.05% versus 48% on vehicle [5].

In two 24-week vehicle-controlled studies of 533 subjects, biopsies showed dose-dependent increases in epidermal and granular-layer thickness, decreased melanin content, and stratum-corneum compaction, with no obvious dermal changes detected [6]. A separate study assessed collagen I formation after 10 to 12 months: 29 patients with photodamaged skin used 0.1% cream (15) or vehicle (14) daily, and collagen I formation rose 80% on tretinoin while falling 14% on vehicle (P=0.006) [1].

Over 40 weeks, 54 black subjects with post-inflammatory hyperpigmentation had significantly lighter facial lesions on 0.1% tretinoin than on vehicle (P<0.001), with 40% versus 18% colorimetric lightening (P=0.05) [3].

What the labels say

Retin-A and Retin-A Micro are labeled for acne. Renova 0.02% cream is labeled only as an adjunct for fine facial wrinkles, and its label says it does not eliminate wrinkles, repair sun-damaged skin, reverse photoaging or restore younger skin [2]. The photodamage studies above used 0.05% or 0.1% creams, not Renova's 0.02%.

The Renova label says not to use the cream if the patient is sunburned, has eczema or other chronic facial skin conditions, or takes photosensitizing drugs such as thiazides, tetracyclines, fluoroquinolones, phenothiazines or sulfonamides, and it recommends sunscreen of at least SPF 15 and protective clothing [2]. It warns of severe local erythema, itching, burning, stinging and peeling, and states that applying larger amounts than recommended has not been shown to give faster or better results and may cause marked redness, peeling or discomfort [2].

Frequently asked questions

When do results first show up on tretinoin?
In a 40-week pigment study, overall improvement was first noted after four weeks [3]. The acne trial reported lesion reductions at 12 weeks (37% with 0.025% gel) [4], and the photodamage study reported overall improvement at 24 weeks (79% with 0.05% versus 48% on vehicle) [5].
How much irritation should I expect?
In the Renova studies of 339 patients, almost all reported one or more local reactions such as peeling, dry skin, burning, stinging, erythema and itching, 32% had irritation that was severe, led to a temporary pause, or led to use of a mild topical corticosteroid, and about 4% discontinued for adverse reactions [2].
Has daily tretinoin use been studied beyond a year?
The Renova label states that neither the safety nor the efficacy of daily use for greater than 52 weeks has been established [2]. The collagen I biopsy study followed patients for 10 to 12 months [1].

References

  1. Griffiths CE, Russman AN, Majmudar G, Singer RS, Hamilton TA, Voorhees JJ. Restoration of collagen formation in photodamaged human skin by tretinoin (retinoic acid). N Engl J Med. 1993;329(8):530-5. Restoration of collagen formation in photodamaged human skin by tretinoin (retinoic acid)
  2. U.S. National Library of Medicine, DailyMed. Renova tretinoin cream 0.02% (Bausch) prescribing information. Renova tretinoin cream 0.02% (Bausch) label
  3. Bulengo-Ransby SM, Griffiths CE, Kimbrough-Green CK, Finkel LJ, Hamilton TA, Ellis CN, et al. Topical tretinoin (retinoic acid) therapy for hyperpigmented lesions caused by inflammation of the skin in black patients. N Engl J Med. 1993;328(20):1438-43. Topical tretinoin (retinoic acid) therapy for hyperpigmented lesions caused by inflammation of the skin in black patients
  4. Shalita A, Weiss JS, Chalker DK, Ellis CN, Greenspan A, Katz HI, et al. A comparison of the efficacy and safety of adapalene gel 0.1% and tretinoin gel 0.025% in the treatment of acne vulgaris: a multicenter trial. J Am Acad Dermatol. 1996;34(3):482-5. A comparison of the efficacy and safety of adapalene gel 0.1% and tretinoin gel 0.025% in the treatment of acne vulgaris: a multicenter trial
  5. Weinstein GD, Nigra TP, Pochi PE, Savin RC, Allan A, Benik K, et al. Topical tretinoin for treatment of photodamaged skin. A multicenter study. Arch Dermatol. 1991;127(5):659-65. Topical tretinoin for treatment of photodamaged skin. A multicenter study
  6. Bhawan J, Gonzalez-Serva A, Nehal K, Labadie R, Lufrano L, Thorne EG, et al. Effects of tretinoin on photodamaged skin. A histologic study. Arch Dermatol. 1991;127(5):666-72. Effects of tretinoin on photodamaged skin. A histologic study
Evidence overview for Tretinoin Year-1 Outcomes: What Real Users Actually Experience