NCT03508856

Clinical and Histologic Evaluation of Picato 0.15% Gel in the Cosmetic Improvement of Photoaged Skin

Completed NA Last updated 26 April 2018

What this trial tests

NA trial testing Ingenol Mebutate (Picato®) 0.015% gel in Actinic Keratosis in 23 participants. Completed in 9 August 2016.

Timeline

9 November 2015

Primary endpoint
9 August 2016

9 August 2016

Quick facts

Lead sponsor	Skin Laser & Surgery Specialists
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	9 November 2015
Primary completion	9 August 2016
Estimated completion	9 August 2016

Drugs / interventions tested

• Ingenol Mebutate (Picato®) 0.015% gel — full drug profile →

Conditions studied

• Actinic Keratosis — all drugs for Actinic Keratosis →
• Photo-aged Skin — all drugs for Photo-aged Skin →

Sponsor

Skin Laser & Surgery Specialists — full company profile →

Who can join

Adults 45 to 75, any sex, with Actinic Keratosis or Photo-aged Skin. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Clinical Evaluation:

Subjects having actinic keratoses and meeting Glogau Photoaging Class III or IV complete the FDA approved 3 day course of Picato® 0.015% gel as approved for the treatment of facial Actinic Keratosis. Each subject undergoes clinical multiple-angle standardized photographs on day 1, day 7, day 30, and day 60. Full face photography will be obtained with the medical research digital camera. Both subjects and investigators complete questionnaires at each visit with individual questions regarding improvement in actinic keratoses and overall skin appearance, wrinkling, dyschromia, erythema, and textural quality of skin. Each characteristic listed above will be graded on a 5 point scale ranging from 0 (lowest quality/worst appearance) to 5 (highest quality/best appearance). In addition, investigators will examine the subject's face and assign a numeric assessment on a 9 point scale ranging from 0 to 8 using previously published verified Griffiths' Photonumeric Photoaging scale. A second and third investigator will be presented at random blinded pretreatment (day 0) and posttreatment (day 60) photographs of each subject and be asked to assign a numerical value from Griffiths' Photonumeric Photoaging Scale. These blinded investgators will be given no information regarding which day each photograph represents. Comparison will be made of skin quality questionnaire scores from each visit and the pre and post treatment Griffiths' Photonumeric Grades.

The investigator opted against a split-face study design given the difficulty of blinding with this type of study as well as difficulty recruiting subjects willing to treat for two separate courses.

Histologic Evaluation:

Standard 3mm dermatology punch biopsies from clinically sun damaged skin will be taken. Biopsy will be taken from either the cosmetically acceptable pre-or infra-auricular area. A digital photograph will be taken and used to identify the pre-treatment biopsy site. Biopsies will be taken of 5 subjects before treatment and at day 60. Day 60 biopsies will be taken immediately adjacent to previously photographed and identified pre-treatment biopsies. Biopsies will be stained with hematoxylin and eosin and histologic features of pre and post treatment skin will be evaluated. Measurement of actinic keratoses, solar elastosis and overall epidermal and dermal thickness pre and post treatment will be compared.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.