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. 2014 Aug 7:7:215-24.
doi: 10.2147/CCID.S63067. eCollection 2014.

A randomized, double-blind, placebo-controlled clinical trial evaluating Dermytol(®) cream for the treatment of actinic keratoses

Malkanthi Evans  1 , Douglas Kalman  2 , Patricia Alvarez  3 , Maryse Paquet  4 , Najla Guthrie  1
Affiliations

A randomized, double-blind, placebo-controlled clinical trial evaluating Dermytol(®) cream for the treatment of actinic keratoses

Malkanthi Evans et al. Clin Cosmet Investig Dermatol. .

Abstract

Purpose: Actinic keratosis lesions (AKs) have the potential to develop into squamous cell carcinoma (SCC) and thus therapies to prevent SCC development from AKs are warranted. The aim of this study was to assess the effects of a 3 month application of a canola phenolic acid-based cream (CPA) on AK lesions.

Patients and methods: This was a randomized, double-blind, placebo-controlled, 12 week clinical study conducted at a single-center in Santo Domingo, Dominican Republic. Forty-five subjects (30 CPA and 15 placebo), aged 45-85 years with 3-10 AKs within a 20 cm(2) treatment area (scalp, forehead, dorsal forearm, neck, or back of hand) were enrolled. The primary outcome was complete or partial lesion clearance and the secondary outcome was safety of CPA.

Results: Although complete AK lesion clearance was not seen in this study, a significant reduction in the mean change from baseline in the average lesion area was observed at weeks 3 (P=0.002), 6 (P<0.001), and 12 (P<0.001) in the CPA group, but only at weeks 6 and 12 in the placebo group (P=0.005 and P=0.002, respectively). Furthermore, the proportion of participants with a $10% decrease in average lesion area was significantly higher in the CPA group than the placebo group at weeks 3 (P=0.05) and 6 (P=0.02), and showed a trend at week 12 (P=0.06). A subset analysis of the change in average lesion area based upon the total lesion area at baseline revealed that CPA elicited a greater reduction than placebo (2×) in participants with a baseline total AK lesion area of 100-500 mm(2) than in participants with a total area <100 mm(2) (1.3×).

Conclusion: The results of this study and previous in vitro studies suggest a potential role for CPA in the treatment of AK lesions and the prevention of SCC development.

Keywords: Dermytol®; actinic keratosis; canola phenolic acid-rich extract; precancerous lesion; squamous cell carcinoma.

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Figures

Figure 1
Figure 1
Illustration of the disposition of all participants screened and enrolled into the study. Abbreviations: AE, adverse effect; CPA, canola phenolic acid-based cream.
Figure 2
Figure 2
Forearm AK lesions. Note: Forearm AK lesions of a participant in the CPA group at (A) baseline and (B) end of study (12 weeks of treatment). Abbreviations: AK, Actinic keratosis lesion; CPA, canola phenolic acid-based cream.
Figure 3
Figure 3
The mean change in lesion size from baseline at 3, 6 and 12 weeks of treatment and after follow-up at 36 weeks. Notes: A significantly larger decrease in the mean change (±95% confidence interval) in average AK lesion area was seen in both CPA (grey bars) and placebo groups (white bars) at 6 and 12 weeks, but only in the CPA at 3 weeks. No difference was seen between the treatment groups. The results at week 36, represent the change in the lesion area from week 12, suggesting that CPA has long-lasting effects beyond the treatment period. *P=0.002, **P<0.001 and †P=0.005 as compared to baseline. Abbreviations: AK, Actinic keratosis lesion; CPA, canola phenolic acid-based cream.
Figure 4
Figure 4
Proportion of subjects exhibiting >10%, >25% and >50% reductions in average lesion size. Notes: A greater proportion of subjects had a >10% resolution in average lesion size in the CPA group (gray bars) than the placebo group (white bars). §P=0.05, §§P<0.05, ¥P=0.06 as compared to the placebo group.
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