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COMPLETEDPHASE4

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

Subject Reported Outcomes on Satisfaction, Safety and Efficacy With Luxerm® in the Field-directed Treatment of Thin or Non-hyperkeratotic and Non-pigmented Actinic Keratosis of the Face or the Scalp

NCT03511326•Galderma R&D

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female age \> 18 years old.
•2. 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.
•3. Subject or caregiver capable of performing the skin preparation and Luxerm® treatment application as per the investigator instructions.
•4. 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).
•5. 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.
•6. Subject has read and signed the approved informed consent form (ICF) prior to any participation in the study.
•7. Subject has read and signed a Photograph Release Consent Form if he/she is willing to be photographed.
•8. Subject (or caregiver) willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol.

Exclusion Criteria

•1. Subject with a clinical diagnosis of a skin disease other than AK (including non-melanoma skin cancer) on the target anatomical area.
•2. Subject with severe AK (thick, hyperkeratotic AK) per anatomical area (face or scalp).
•3. Subject with clinical diagnosis of other skin disease on the target anatomical area.
•4. Subject with pigmented AK on the target anatomical area.
•5. Subject with melanoma at any location.
•6. Immunocompromised subject or requiring immunosuppressive therapies.
•7. Subject with porphyria; photosensitivity- related disorders, active infectious disease.
•8. Subject with known or suspected hypersensitivity to the active substance or to any excipients of Luxerm® (see Summary of Product Characteristics).
•9. Female subject who is pregnant, nursing or planning a pregnancy during the study.
•10. 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.
+17 more criteria

Locations (1)

University Hospital Regensburg

Regensburg, Germany

Key Dates

Start Date

June 7, 2017

Primary Completion Date

November 28, 2017

Completion Date

November 28, 2017

Last Updated

February 18, 2021

Enrollment

ACTUAL participants

Conditions

Actinic Keratoses

Interventions

Methyl Aminolaevulinate 16% Cream

DRUG

Investigation of the Effect of Lipikar Baume AP+M

NCT06385340

Actinic Keratoses

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RECRUITING

SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography

NCT06321003

Oral Squamous Cell CarcinomaOral Potentially Malignant Disorder+10 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Investigation of the Effect of Lipikar Baume AP+M

SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography

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