SESAME 2: PRO With Luxerm® in the Field Treatment of Thin and Non-hyperkeratotic Non-pigmented AK

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03511326
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.7
• Patients Per Site Per Month: 8.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Actinic Keratoses	Drug: Methyl Aminolaevulinate 16% Cream	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: 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
• Actual Study Start Date: Jun 7, 2017
• Actual Primary Completion Date: Nov 28, 2017
• Actual Study Completion Date: Nov 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Luxerm®	Drug: Methyl Aminolaevulinate 16% Cream; Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy; Other Names: 160mg/g of methyl aminolevulinate

Outcome Measures

Primary Outcome Measures

1. Overall Subject Satisfaction the Day of Treatment After Daylight Session [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

2. Overall Subject Satisfaction at Week 12 Post-treatment [Week 12]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

11. 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

• 5-FU, imiquimod ==>24 weeks

• Surgical: excision and reconstructive surgery, chemosurgery, ==>12 weeks

• Any Photodynamic Therapy, ingenol mebutate (Pep-005), Radiotherapy and UV radiation therapy==>12 weeks

• Investigational therapies for Actinic Keratoses==>12 weeks

• Immunosuppressive drugs (such as glucocorticoids, cytostatic, antibodies, drugs acting on interferon, opioids, TNF binding proteins, Mycophenolate, small biologics agents)==>12 weeks

1. Subject who is currently participating to/ or who has participated in another investigational treatment or device research study within 4 weeks of baseline visit.

2. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.

3. Subject who is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.

4. Subject who is unwilling to refrain from use of prohibited medication during the clinical trial (see section 4.3.5).

5. Subject who is vulnerable (such as deprived of freedom) as defined in Section 1.61 of the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP).

6. Subject with clinically significant abnormal laboratory finding (if any available report) at the baseline visit or medical/surgical condition (other than for actinic keratoses), which might, in the Investigator's opinion, interfere with study evaluations or pose a risk to subject safety during the study.

7. The subject is a study site staff member (investigator, study nurse, etc.) or a relative of one.

8. Subjects with any condition that may be associated with a risk of poor protocol compliance

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Regensburg	Regensburg		Germany

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Director: Rajeev CHAVDA, MD, Galderma R&D

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 22, 2017

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT03511326
• Other Study ID Numbers: RD.03.SPR.114384
• First Posted: Apr 27, 2018
• Last Update Posted: Feb 18, 2021
• Last Verified: Sep 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Galderma R&D: field-treatment
• Additional relevant MeSH terms: Keratosis, Actinic; Keratosis; Aminolevulinic Acid; Methyl 5-aminolevulinate

Study Results

Participant Flow

Arm/Group Title	Luxerm®
Arm/Group Description	Methyl Aminolaevulinate 16% Cream: Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy
Period Title: Overall Study
STARTED	50
COMPLETED	49
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Luxerm®
Arm/Group Description	Methyl Aminolaevulinate 16% Cream: Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy
Overall Participants	50
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 18%
>=65 years	41 82%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.4 (8)
Sex: Female, Male (Count of Participants)
Female	7 14%
Male	43 86%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	50 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Germany	50 100%
Skin phototype (Count of Participants)
Phototype I	7 14%
Phototype II	35 70%
Phototype III	8 16%
Duration of Actinic Keratosis (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	7.77 (6.78)

Outcome Measures

1. Primary Outcome

Title	Overall Subject Satisfaction the Day of Treatment After Daylight Session
Description	Percentage of subjects satisfied and very satisfied globally with Luxerm Daylight procedure, the day of treatment after daylight session
Time Frame	the day of treatment after daylight session

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) population included all enrolled participants (i.e. treatment dispensed).

Arm/Group Title	Luxerm®
Arm/Group Description	Methyl Aminolaevulinate 16% Cream: Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy
Measure Participants	50
Count of Participants [Participants]	47 94%

2. Primary Outcome

Title	Overall Subject Satisfaction at Week 12 Post-treatment
Description	Percentage of subjects satisfied or very satisfied (overall) with Luxerm DL procedure
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

ITT population included all enrolled participants (i.e. treatment dispensed). Here, the "N" number of participants analyzed signifies participants who were evaluable for this outcome measure.

Arm/Group Title	Luxerm®
Arm/Group Description	Methyl Aminolaevulinate 16% Cream: Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy
Measure Participants	48
Count of Participants [Participants]	41 82%

Adverse Events

Time Frame	From signing of Informed Consent Form (ICF) to end of study (Week 12)
Arm/Group Title	Luxerm®
Arm/Group Description	Methyl Aminolaevulinate 16% Cream: Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy
All Cause Mortality
	Luxerm®
	Affected / at Risk (%)	# Events
Total	0/50 (0%)
Serious Adverse Events
	Luxerm®
	Affected / at Risk (%)	# Events
Total	0/50 (0%)
Other (Not Including Serious) Adverse Events
	Luxerm®
	Affected / at Risk (%)	# Events
Total	28/50 (56%)
Infections and infestations
Rhinitis	1/50 (2%)	1
Wound infection	1/50 (2%)	1
Injury, poisoning and procedural complications
Procedural pain	15/50 (30%)	15
Skin and subcutaneous tissue disorders
Erythema	19/50 (38%)	20
Pruritus	1/50 (2%)	1
Skin burning sensation	8/50 (16%)	8
Skin discolouration	1/50 (2%)	1
Skin exfoliation	1/50 (2%)	1
Skin irritation	1/50 (2%)	1
Skin tightness	1/50 (2%)	1
Skin warm	1/50 (2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.