Retinova / Renova : Product Information
Retinova (sold under trade name Renova in the US).
Indications
Retinova is for the topical treatment of mottled hyperpigmentation, roughness and fine wrinkling of photodamaged skin due to chronic sun exposure.
Background Information
Cumulative damage to the skin, due to Ultraviolet (UV) radiation from chronic sun exposure, may result in visible clinical changes characterised as photo-ageing (dermatoheliosis) or photodamage. These include both fine and coarse wrinkling and a yellow, lax, rough, telangiectatic and mottled hyperpigmentation of the skin. These clinical changes are accompanied by characteristic histologic changes such as epidermal dysplasia with cytologic atypia, dermal damage with marked elastosis, loss of collagen, increased melanocytic activity, loss of polarity of keratinocytes, an increase in glycosaminoglycans and a modest inflammatory infiltrate.
Dosage and Administration
In adults and elderly patients, tretinoin should be applied once daily, at night, in sufficient quantities to lightly cover the affected areas. Once the maximum beneficial effect has been achieved (3-6 months) it can be maintained by continuing to apply tretinoin cream one to three times a week.
Clinical Efficacy
The two largest trials,2,3 involved a total of over 600 healthy Caucasian subjects with mild or moderate facial photodamage. In one study2 299 such subjects were randomised to treatment with an emollient cream formulation of tretinoin (TEC) 0.05% (n = 100), 0.01% (n = 100) or control vehicle (n = 99) applied once daily to the face for 24 weeks. Thirty-six subjects withdrew from the study including 12 subjects who withdrew due to an adverse skin reaction. 86% and 61% of subjects showed a statistically significant global improvement (graded by the investigator) with 0.05% TEC (p < 0.001) and 0.01% TEC (p < 0.05) respectively, compared with 44% of control subjects. Fine wrinkling (p < 0.001); mottled hyperpigmentation (p < 0.001); roughness (p = 0.012) and laxity (p = 0.001) showed significant improvement with 0.05% TEC compared with vehicle. Eighty-seven percent of patients using 0.05% TEC judged their skin to be improved relative to baseline compared with 43% of the vehicle group.
In the second study 320 subjects were randomised to treatment with TEC 0.05%, 0.01%, 0.001% or control vehicle, with 80 patients in each treatment arm. The treatment cream was applied to the entire face once each evening for 24 weeks. A total of 24 patients withdrew from the study including 4 subjects who withdrew due to an adverse skin reaction. At 24 weeks, subjects receiving TEC 0.05% showed significantly greater global improvement (p < 0.001) and reduction in overall severity (p = 0.002) than those receiving vehicle. Mottled hyperpigmentation, fine wrinkling and roughness were decreased to a significantly greater extent following treatment with TEC 0.05% compared with vehicle (p < 0.05). Seventy-eight percent of patients using 0.05% TEC judged the appearance and feel of their skin to be improved relative to baseline compared with 70% of the 0.01% TEC group; 60% of the 0.001% TEC group and 61% of the vehicle group.
The histologic data from these two studies were reported separately. A significantly greater increase from baseline in epidermal thickness was seen with 0.05% TEC (p < 0.001) and 0.01% TEC (£ 0.002) than with vehicle-treated patients. A similar dose-dependent increase in granular thickness was also found after therapy. This increase was statistically significant between 0.05% TEC and vehicle groups (p < 0.001) and 0.01% TEC and vehicle groups (p £ 0.004).
The percentage of patients who exhibited a compaction of the stratum corneum was significantly greater with 0.05% TEC (p £ 0.002) and 0.01% TEC (p £ 0.02) than with vehicle-treated patients. Melanin content decreased significantly from baseline after 24 weeks of therapy, declining to a significantly greater extent in the 0.05% TEC groups compared with the vehicle group (p = 0.017).
The effect of longer term treatment on hyperpigmentation was investigated in 60 healthy white patients who were randomly assigned to receive either tretinoin 0.1% (n = 30) or vehicle (n = 30) applied once nightly to face, arms, forearms and backs of hands for ten months. After ten months, a statistically significant lightening of hyperpigmented facial and upper-extremity lesions was demonstrated in 83% to 88% of patients in the tretinoin group compared to 29% of patients in the vehicle group (p < 0.002). Fifteen patients who had received tretinoin went on to receive a further six months of either continued tretinoin treatment (n = 8) or vehicle (n = 7). The group re-assigned to tretinoin treatment had a further overall improvement of lightening of lesions. In contrast there was no further improvement in patients who received vehicle during the six month follow-up. However, lightening and resolution of lesions seen during the first ten months of treatment were not visibly reversed during this period of discontinuation.
The efficacy of topical tretinoin has been assessed in the treatment of photo-ageing in racial groups other than Caucasians. In these trials, topical tretinoin has been shown to significantly lighten post-inflammatory hyperpigmented lesions (p < 0.001) and melasma in black patients and to significantly lighten the hyperpigmentation of photo-aging in Chinese and Japanese patients (p < 0.05).
Adverse Effects
In clinical trials with topical tretinoin, the only adverse reaction seen was cutaneous irritation. Mild to moderate skin reactions (eg dryness, peeling, erythema, burning, stinging, pruritis) were seen in up to 92% of patients treated with tretinoin, with higher incidence being seen with higher concentrations.3 Adverse effects were responsible for about 3% of patients being withdrawn from the studies.
Topical tretinoin should not be used during pregnancy as there have been reports of congenital defects associated with maternal use.
Summary
There is evidence from controlled clinical trials in large numbers of patients that tretinoin 0.05% cream can improve some of the clinical signs of photo-aging. The only adverse drug effects associated with this treatment are cutaneous irritation and dermatitis. However, the use of measures to prevent photodamage should not be undermined and avoidance of sun exposure and use of high protection sunblock are undoubtedly still the most rational approaches to preventing photodamage.
Package Quantity
20g per tube.
Further Information
RETINOVA also contains: Paraffin light liquid, Sorbital Solution, Edetate Disodium, Methylparahydroxybenzoate, Dimethicone, Quaternium-15, Hydroxyoctacosanyl Hydroxystearate, Methoxy PEG-22/Dodecyl Glycol Copolymer, PEG-45/Dodecyl Glycol Copolymer, Stearoxytrimethylsaline and Stearyl Alcohol, Citric Acid Monohydrate, Butylated Hydroxytoluene, Fragrance and Purified water.
Store below 25°C (77°F). Do not freeze.
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