TreatMent of ActInic KerAtosis Lesions : pharmacoepiDemiological Study of the Impact in Real Life of ingenOl Mebutate Gel (Picato®) on Patients Satisfaction

NCT04202445 | Completed

• 1 other identifier: NIS-PICATO-1087
• Study Type: observational
• Target: 1,218
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an observational longitudinal study, prospective, multicenter, performed in metropolitan France, on a representative sample of dermatologists. Data will be collected by physicians during 2 or 3 visits (according to their usual practice), from the patient file, questioning and clinical examination performed during these visits. Data about the patient's perception (satisfaction, perception of local skin reactions, quality of life) will be collected directly by the patient using self-administered questionnaires at inclusion visit, day 7 and 2 months later.

Conditions

Actinic Keratosis

Keywords

Actinic keratosis; Field treatment; Ingenol mebutate; Picato; Mikado

Outcome Measures

Primary Outcomes (1)

• Treatment Satisfaction Questionnaire of Medication (TSQM-9)

  The TSQM-9 scale is a 7-item instrument to be completed by patients. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domaine.

  2 months after end of treatment

Secondary Outcomes (2)

• Dermatology Life Quality Index - DLQI

  Baseline and 2 months after end of treatment

• Real-life efficacy of Picato

  Between Day 1 after the treatment application and 12 months (maximum 2 follow-up visits after the inclusion)

Interventions

Ingenol mebutate DRUG

Topical field treatment as prescribed by dermatologist

Also known as: Picato

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with actinic keratosis planned to receive treatment with ingenol mebutate at the discretion of the dermatologist

You may qualify if:

• Patient at least 18 years old, seen by the dermatologist during a consultation, whether actinic keratosis is the reason for consultation or not.
• Patient with AK lesions and for whom the dermatologist decided to initiate a treatment with Picato®\* 150 or Picato®\* 500

You may not qualify if:

• Patient with a contraindication to treatment with Picato®.
• Patient unable to read and/or to understand a self-administered questionnaire.
• Patient already included in the study.
• Patient participating or having participated in the previous month in a clinical trial in dermatology.

Sponsors & Collaborators

• LEO Pharma: lead

Related Publications (12)

• Frost CA, Green AC. Epidemiology of solar keratoses. Br J Dermatol. 1994 Oct;131(4):455-64. doi: 10.1111/j.1365-2133.1994.tb08544.x.

  PMID: 7947197 BACKGROUND

• Memon AA, Tomenson JA, Bothwell J, Friedmann PS. Prevalence of solar damage and actinic keratosis in a Merseyside population. Br J Dermatol. 2000 Jun;142(6):1154-9. doi: 10.1046/j.1365-2133.2000.03541.x.

  PMID: 10848739 BACKGROUND

• Quaedvlieg PJ, Tirsi E, Thissen MR, Krekels GA. Actinic keratosis: how to differentiate the good from the bad ones? Eur J Dermatol. 2006 Jul-Aug;16(4):335-9.

  PMID: 16935787 BACKGROUND

• Dinehart SM. The treatment of actinic keratoses. J Am Acad Dermatol. 2000 Jan;42(1 Pt 2):25-8. doi: 10.1067/mjd.2000.103338.

  PMID: 10607354 BACKGROUND

• French Society of Dermatology. [Guidelines for the diagnosis and treatment of cutaneous squamous cell carcinoma and precursor lesions. Arguments - May 2009]. Ann Dermatol Venereol. 2009 Sep;136 Suppl 5:S189-242. No abstract available. French.

  PMID: 19795558 BACKGROUND

• Thai KE, Fergin P, Freeman M, Vinciullo C, Francis D, Spelman L, Murrell D, Anderson C, Weightman W, Reid C, Watson A, Foley P. A prospective study of the use of cryosurgery for the treatment of actinic keratoses. Int J Dermatol. 2004 Sep;43(9):687-92. doi: 10.1111/j.1365-4632.2004.02056.x.

  PMID: 15357755 BACKGROUND

• Burge SM, Bristol M, Millard PR, Dawber RP. Pigment changes in human skin after cryotherapy. Cryobiology. 1986 Oct;23(5):422-32. doi: 10.1016/0011-2240(86)90027-1.

  PMID: 3769517 BACKGROUND

• Zouboulis CC. Cryosurgery in dermatology. Eur J Dermatol. 1998 Oct-Nov;8(7):466-74.

  PMID: 9854156 BACKGROUND

• Fu W, Cockerell CJ. The actinic (solar) keratosis: a 21st-century perspective. Arch Dermatol. 2003 Jan;139(1):66-70. doi: 10.1001/archderm.139.1.66. No abstract available.

  PMID: 12533168 BACKGROUND

• Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012 Mar 15;366(11):1010-9. doi: 10.1056/NEJMoa1111170.

  PMID: 22417254 BACKGROUND

• Anderson L, Schmieder GJ, Werschler WP, Tschen EH, Ling MR, Stough DB, Katsamas J. Randomized, double-blind, double-dummy, vehicle-controlled study of ingenol mebutate gel 0.025% and 0.05% for actinic keratosis. J Am Acad Dermatol. 2009 Jun;60(6):934-43. doi: 10.1016/j.jaad.2009.01.008.

  PMID: 19467365 BACKGROUND

• Berman B. New developments in the treatment of actinic keratosis: focus on ingenol mebutate gel. Clin Cosmet Investig Dermatol. 2012;5:111-22. doi: 10.2147/CCID.S28905. Epub 2012 Aug 24.

  PMID: 22956883 BACKGROUND

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sarah Moumane, MD

  LEO Pharma

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: December 17, 2019
• Study Start: April 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 9, 2023

Record last verified: 2019-12