Efficacy and Safety of Cryotherapy followed by Tirbanibulin ointment for actinic keratosis on the scalp and forehead

Conditions

Patients (male or female) ≥18 years old with scalp and forehead actinic keratoses

Brief summary

Complete response rate of actinic keratosis at 8 months. A complete response corresponds to the absence of clinically detectable actinic keratosis in the treated area.

Detailed description

Complete response rate for actinic keratosis at 12 months., Partial response rate (= 75% reduction of lesions) at 8 months., Partial response rate (= 75% reduction of lesions) at 12 months., Number of cryotherapy sessions carried out over the follow-up period., Collection of the following local skin reactions: erythema, desquamation, crusts, oedema, vesicles/pustules, erosions/ulcerations and gradation on a scale from 0 to 3: 0=absent, 1=light (barely perceptible), 2=moderate (obvious presence), 3=severe (marked, intense). Assessment of pain using a visual analogue scale from 0 to 10., The photographs taken during the visits will be analysed using computer-aided image processing.

Related papers

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Interventions

DRUGKlisyri 10 mg/g ointment

DRUGLe placebo possède les mêmes caractéristiques que le traitement Klisyri 10mg/g sans la substance active. Il est produit et fourni par le même producteur que le Klisyri.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Complete response rate of actinic keratosis at 8 months. A complete response corresponds to the absence of clinically detectable actinic keratosis in the treated area.	—

Secondary

Measure	Time frame
Complete response rate for actinic keratosis at 12 months., Partial response rate (= 75% reduction of lesions) at 8 months., Partial response rate (= 75% reduction of lesions) at 12 months., Number of cryotherapy sessions carried out over the follow-up period., Collection of the following local skin reactions: erythema, desquamation, crusts, oedema, vesicles/pustules, erosions/ulcerations and gradation on a scale from 0 to 3: 0=absent, 1=light (barely perceptible), 2=moderate (obvious presence), 3=severe (marked, intense). Assessment of pain using a visual analogue scale from 0 to 10., The photographs taken during the visits will be analysed using computer-aided image processing.	—

Measure

Time frame

Complete response rate for actinic keratosis at 12 months., Partial response rate (= 75% reduction of lesions) at 8 months., Partial response rate (= 75% reduction of lesions) at 12 months., Number of cryotherapy sessions carried out over the follow-up period., Collection of the following local skin reactions: erythema, desquamation, crusts, oedema, vesicles/pustules, erosions/ulcerations and gradation on a scale from 0 to 3: 0=absent, 1=light (barely perceptible), 2=moderate (obvious presence), 3=severe (marked, intense). Assessment of pain using a visual analogue scale from 0 to 10., The photographs taken during the visits will be analysed using computer-aided image processing.

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Countries

France

Outcome results

None listed