PRO With Luxerm® in the Field Treatment of Thin and Non-hyperkeratotic Non-pigmented AK

NCT03511326 | Completed Phase 4 Results

• 1 other identifier: RD.03.SPR.114384
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Interventional open label prospective and multicentre study conducted in Germany in subjects with thin or non-hyperkeratotic and non-pigmented multiple AKs in one anatomical area on the face (e.g., forehead or cheek or chin), excluding nose eyelids, lips and mucosa or balding scalp, using Luxerm® DL-PDT treatment.

Conditions

Actinic Keratoses

Keywords

field-treatment

Outcome Measures

Primary Outcomes (2)

• Overall Subject Satisfaction the Day of Treatment After Daylight Session

  Percentage of subjects satisfied and very satisfied globally with Luxerm Daylight procedure, the day of treatment after daylight session

  the day of treatment after daylight session

• Overall Subject Satisfaction at Week 12 Post-treatment

  Percentage of subjects satisfied or very satisfied (overall) with Luxerm DL procedure

  Week 12

Study Arms (1)

Luxerm®

EXPERIMENTAL

Drug: Methyl Aminolaevulinate 16% Cream

Interventions

Methyl Aminolaevulinate 16% Cream DRUG

Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy

Also known as: 160mg/g of methyl aminolevulinate

Luxerm®

Eligibility Criteria

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

You may qualify if:

• Male or female age \> 18 years old.
• Subject with at least 5 clinically confirmed thin or non-hyperkeratotic and non-pigmented actinic keratoses in an anatomical area on the face (e.g., forehead or cheek or chin) excluding nose, eyelids, lips and mucosa, or balding scalp, at baseline visit.
• Subject or caregiver capable of performing the skin preparation and Luxerm® treatment application as per the investigator instructions.
• Female subject of childbearing potential must have a negative UPT at baseline (UPT should have a sensitivity of 25 IU/L or less) and agree to be strictly abstinent or use a highly effective method of birth control during the study (i.e. progestogen-only oral hormonal contraception; male or female condom; cap, diaphragm or sponge with spermicide; bilateral tubal ligation; combined (estrogen and progestogen-containing) oral hormonal contraception, or injectable or implants hormonal contraception (at a stable dose for at least 1 month prior to baseline); intra-uterine devices inserted at least 1 month prior to baseline; vasectomized partner for at least 3 months prior to baseline).
• Female subject of non-childbearing potential, e.g.: post-menopausal (absence of menstrual bleeding for 1 year without any other medical reason), hysterectomy or bilateral ovariectomy.
• Subject has read and signed the approved informed consent form (ICF) prior to any participation in the study.
• Subject has read and signed a Photograph Release Consent Form if he/she is willing to be photographed.
• Subject (or caregiver) willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol.

You may not qualify if:

• Subject with a clinical diagnosis of a skin disease other than AK (including non-melanoma skin cancer) on the target anatomical area.
• Subject with severe AK (thick, hyperkeratotic AK) per anatomical area (face or scalp).
• Subject with clinical diagnosis of other skin disease on the target anatomical area.
• Subject with pigmented AK on the target anatomical area.
• Subject with melanoma at any location.
• Immunocompromised subject or requiring immunosuppressive therapies.
• Subject with porphyria; photosensitivity- related disorders, active infectious disease.
• Subject with known or suspected hypersensitivity to the active substance or to any excipients of Luxerm® (see Summary of Product Characteristics).
• Female subject who is pregnant, nursing or planning a pregnancy during the study.
• Subject who has used any of the following topical preparations on the area to be treated: keratolytics including urea (greater than 5%), alpha hydroxyacids \[e.g. glycolic acid, lactic acid, etc. greater than 5%\], salicylic acid (greater than 2%) within 2 days of initiation of treatment.
• Subject with a wash-out period from baseline for topical or systemic treatment or medical/surgical procedure in the anatomical area (for AKs) less than the following:
• Retinoids, including tazarotene, adapalene, tretinoin, retinol ==\> 4 weeks
• Cryotherapy, diclofenac, corticosteroids or other treatments for AK==\> 8 weeks
• Microdermabrasion, laser ablative treatments or chemical peels ==\>8 weeks
• FU, imiquimod ==\>24 weeks

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

University Hospital Regensburg

Regensburg, Germany

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

methyl 5-aminolevulinate

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: CTA Coordinator
• Organization: Galderma R&D SNC

cta.coordinator@galderma.com

+33 0493 95 70 85

Study Officials

• Rajeev CHAVDA, MD

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: April 27, 2018
• Study Start: June 7, 2017
• Primary Completion: November 28, 2017
• Study Completion: November 28, 2017
• Last Updated: February 18, 2021
• Results First Posted: December 10, 2020

Record last verified: 2018-09

Locations

DE (1)