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Introduction: Sunscreen protection in subjects with actinic keratosis (AK) is highly recommended to prevent clinical evolution of this in situ skin cancer condition. Use of topical anti-cyclooxygenase drugs such as diclofenac and piroxicam reduces the number of lesions and improves the cancerization field. A film-forming medical device in a cream formulation containing organic and inorganic sun-filters (50+ SPF) and piroxicam 0.8% (ACTX) has shown in a pilot, single-center, open trial to reduce AK lesions improving the cancerization field.Aim: We evaluated in a multicenter, assessor-blinded, 3 month trial the efficacy of ACTX in AK.Methods: A total of 70 subjects with at least three AK lesions on the scalp or face were enrolled after written informed consent. Primary outcomes of the study were the clinical evolution of number of AK lesions on a target zone area and the evolution of dermoscopy features of the target lesion, assessing erythema, scaling, pigmentation, and follicular plug, using a 5 point score (from 0 to 4; maximum score: 16). Lesion count and dermoscopy score were evaluated in a blind fashion assessing digital color high definition coded images. A secondary outcome was the Investigator Global Score (IGS) of clinical evolution of the target area using a 7 point scale from -2 (significantly worse) to +4 (completely cured). IGS was evaluated in an open fashion. Subjects were instructed to apply the cream twice daily on the target area, using one finger-tip unit for the treatment of a 35 cm2 area.Results: All but one subject (40 men and 30 women, mean age 73 years) concluded the study period. At baseline the mean (±SD) number of AK lesions in the target area were 7.0 (5.9) with a median value of 5 and the dermoscopy score of the target lesion was 7.0 (2.3) with a median value of 7.0. ACTX treatment reduced AK lesions to 3.2 (2.9), (p = .0001; Wilcoxon Test), representing a 55% relative reduction. Dermoscopy score was reduced to 3.3 (2.6) (p = .0001) (a reduction of 53%). The IGS after ACTX treatment was +1.9 (1.1), with a median of 2.0. A total of 86% of subjects showed a clinical improvement of IGS (≥1) with a very significant/complete clearance (score +3 or +4) in 42% subjects. No change or a worsening of AK lesions was observed in 14% of the subjects. The product was well tolerated. No serious adverse events were reported during the duration of the trial.Conclusion: In this multicenter, assessor-blinded trial, the use of a film-forming medical device with sun protection and anti-inflammatory actions was effective in reducing AK lesions and improving the dermoscopy aspect of the target lesion in 86% of treated subjects. A head-to-head trial evaluating the efficacy of this medical device in comparison with diclofenac is warranted to establish whether this therapeutic approach could offer additional advantages in term of AK lesion reduction compared to an established topical treatment. (Trial ID: ISRCTN72020277). [ABSTRACT FROM AUTHOR]

• Conventional photodynamic therapy (cPDT) is an effective treatment for actinic keratosis (AK) but its use is limited by the procedure-associated pain. • A self-occlusive lidocaine 7 % tetracaine 7 % cream approved for topical anesthesia is available. There are no data regarding its pain reducing effects in cPDT. • We perform a prospective, randomized, single-blind trial (3P-trial) to assess the pain reduction effects of this cream versus vehicle in 50 subjects with AK undergoing cPDT. • In the active treated group the VAS pain score was reduced by 47 % in comparison with control group (P = 0.0009). • The 3P-trial has demonstrated that the lidocaine 75 tetracaine 7% cream is very effective in reducing the procedure-associated pain during cPDT for the treatment of AK. Conventional photodynamic therapy (cPDT) is considered a very effective treatment of actinic keratosis (AK) lesions. However, its use is limited by the fact that this procedure could be very painful. The use of topical anesthetics such as tetracaine or lignocaine/prilocaine has shown disappointing results in term of pain reduction. A self-occlusive topical 7% lidocaine/7% tetracaine anesthetic cream (LT-C) approved by the FDA to provide local topical anesthesia in adults undergoing superficial dermatological procedures is available. There are no data regarding its pain reducing effect during cPDT. We perform a prospective, randomized, single-blind, two-center trial ( The 3P-Trial ) to assess the pain reduction effect of LT-C versus vehicle in subjects with AK undergoing cPDT. Fifty AK subjects (74 ± 10 years, 32 men, 18 women) with on average 17 lesions were enrolled after their written informed consent. Eight subjects presented also a total of 16 basal cell carcinoma lesions. Twenty-five were randomized to LT-cream, applied 1 h before the Methyl amino levulinate (MAL)-cPDT session and 25 to cream vehicle. The main outcome was the patient-assessed evaluation of pain score during and just after the conclusion of cPDT session (mean of the two values) using a 10-point visual analog scale (VAS). The cPDT session (LED Red light 630 nm) was performed with a duration of 6 ± 2 min with a standard fluence of 37 J/cm2. All treated lesions were prepared by gentle superficial curettage. All the randomized subjects concluded the trial. The mean ± SD of VAS score in vehicle group was 6.2 ± 2.7 (95 % CI of the mean: 5.0–7.5). In the group treated with LT-cream the VAS score was 3.3 ± 1.9 (95 % CI of the mean: 2.5–4.1). The active cream reduced the VAS score by 47 %. Median values of pain VAS score in the active group was reduced by 60 % in comparison with vehicle group (3.0 vs 7.5). The difference between the two groups was statistically significant (p = 0.0009; Mann-Whitney test). The 3P-trial has demonstrated that the preventive application of the self-occlusive lidocaine 7%-tetracaine 7% cream is very effective in reducing the procedure-associated pain during MAL-cPDT for the treatment of AK lesions. [ABSTRACT FROM AUTHOR]