Keratosis, ActinicPHOS-ISTOSNCT03076892
Evaluation of Non-inferiority and Tolerability of the Device PHOS-ISTOS
A study testing Aktilite® Galderma and PHOS ISTOS PDT in people with Keratosis, Actinic, run by University Hospital, Lille at 2 sites in 2 countries.
Trial summary
This study aims to compare the efficacy and tolerance of a new photodynamic therapy device (PHOS-ISTOS) with the conventional PDT device (Aktilite®) for the treatment of actinic keratosis of the scalp Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratosis, Actinic
- What is being tested?
- Aktilite® Galderma and PHOS ISTOS PDT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of minimum 10 previously untreated not pigmented, non-hyperkeratotic AK lesions of Grade I and II of the forehead and/or scalp (according to Olsen et Al. JAAD 1991, cf. REF 31) where other therapies are unacceptable or considered medically less appropriate with a symmetrical repartition on both side of the forehead and/or scalp. The diagnosis of AK will be determined upon clinical evaluation (i.e. visual inspection and palpation) by the investigator.
- No treatment for the AKs in the previous 30 days.
- Symmetrical areas in terms of number and severity of lesions. The axis of symmetry between the two areas will be defined by the investigator according to the distribution of lesions.
- The two areas to be treated should not be coalescing. A minimum distance of 10 mm is required between the lesions located on the 2 symmetrical areas. A minimum distance of 2 mm is required between the lesions on the same side.
- Minimum 5 lesions with similar dimensions at both symmetrical areas will be treated. If the number of lesions is >7, only 7 lesions on each side will be considered.
Who cannot join
- Patients with porphyria.
- Patients immunosuppressed for idiopathic, disease specific or therapeutic reasons.
- Use of topical corticosteroids to lesional areas within 2 weeks before PDT.
- Patients receiving local treatment (including cryotherapy and curettage-electrocoagulation, any PDT treatment) in face / scalp area within the last 30 days.
- Patients receiving topical treatment (including imiquimod, 5-FU and diclofenac, Picato) in face / scalp area within the last 30 days.in
- Use of topical retinoids or alpha-hydroxy acids, systemic retinoids, chemotherapy or immunotherapy within 30 days of PDT.
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- Pigmented AK lesion(s).
- Known allergy to Metvixia/Metvix, a similar PDT compound or excipients of the cream including arachis oil, or to peanut or soya.
- Participation in other clinical studies either currently or within the last 30 days.
- Female subjects must be of either:
- Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
- Childbearing potential, provided there is a confirmed negative urine pregnancy test or blood analysis prior to study treatment, to rule out pregnancy.
- Any condition which may be associated with a risk of poor protocol compliance.
- Patients currently receiving regular ultraviolet radiation therapy.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase II Study Evaluating the Non-inferiority and Better Tolerability of the Device PHOS-ISTOS Compared to the Conventional Photodynamic Therapy (PDT)
This study aims to compare the efficacy and tolerance of a new photodynamic therapy device (PHOS-ISTOS) with the conventional PDT device (Aktilite®) for the treatment of actinic keratosis of the scalp
Read the detailed description
The study is an intraindividual comparison of two methods. The number of subjects to be enrolled is 47. Patients will receive both treatments in a single visit: A first period of 2.5 hours of illumination with Phos-Istos device followed by a continuous red light spectrum (between 7 and 10 minutes) with Aktilite® after an appropriate incubation of MAL (methyl aminolevulinate). Patients will complete a pain assessment scale after receiving both treatments. 3 follow-up visits will be then scheduled
- Conditions
- Keratosis, Actinic
- Being tested
- Aktilite® Galderma, PHOS ISTOS PDT
- Keywords
- PDT, Methyl Aminolevulinate, light emitting textile
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aktilite® GaldermaDevice
Also called Conventional PDT
preparation of the lesions, Metvixia application + occlusive dressing during 3 hours + illumination: 7 to 10 minutes
PHOS ISTOS PDTDevice
preparation of the lesions, Metvixia application + occlusive dressing during 30 minutes + illumination: 2.5 hours
| Study group | Role | What they receive |
|---|---|---|
| Conventional PDT | Active comparator | Aktilite® Galderma Receives: Device: Aktilite® Galderma |
| PHOS ISTOS PDT | Experimental | Light Emitting textile device Receives: Device: PHOS ISTOS PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treated lesion response rate
Each treatment area will be counted, graded with Clinical grade of AK, mapped and photographed
Measured: up to Month 6
Secondary outcomes (5)
Visual analog scale of pain
measure the pain and local tolerance graduation range 0 to 10.
Measured: at Day 1 and Day 7
Scale for clinical assessment of the subject's skin aspect
4-point scale that ranged of Excellent :No scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared to adjacent skin Good: No scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin Fair: Slight to moderate occurrence of scarring, atrophy or induration Poor : Extensive occurrence of scarring, atrophy or induration
Measured: at Month 3 and Month 6
Rate of patients with at least 75% of reduction of the lesions
The response rate is calculated in relation to the initial number of lesions: Response rate is validated if rate ≥ 4 lesions destroyed for 5 initial lesions, ≥ 5 for 6 lesions and ≥ 6 for 7 lesions
Measured: at Month 3 and Month 6
Dermatology Life Quality Index (DLQI )
The questionnaire of 10 questions is completed by the patient to evaluate his quality of life
Measured: at day 1 , Day 7, Month 3 and Month 6
Satisfaction autoquestionnaire
The questionnaire is created by investigator to evaluate the comfort of device.
Participants will answer 9 questions on a 5-point scale that ranged from Not embarrassing,few embarrassing, Embarrassing, Very embarrassing, Don't know
Measured: at Day 7, Month 3 and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study startSep 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Keratosis, ActinicStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Split Face intra individual comparison
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Laurent Mortier, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076892
- Sponsor's protocol ID
- 2015_79
- Other IDs
- 2016-A00010-51
- Acronym
- PHOS-ISTOS
- Status last verified
- Nov 2017
- First submitted
- 7 Mar 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vignion-Dewalle AS, Abi Rached H, Thecua E, Lecomte F, Deleporte P, Behal H, Hommel T, Duhamel A, Szeimies RM, Mortier L, Mordon S. A New Light-Emitting, Fabric-Based Device for Photodynamic Therapy of Actinic Keratosis: Protocol for a Randomized, Controlled, Multicenter, Intra-Individual, Phase II Noninferiority Study (the Phosistos Study). JMIR Res Protoc. 2019 Apr 26;8(4):e12990. doi: 10.2196/12990.
PubMed 31025953
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating the Non-inferiority and Better Tolerability of the Device PHOS-ISTOS Compared to the Conventional Photodynamic Therapy (PDT)
- ClinicalTrials.gov ID
- NCT03076892
- Acronym / sponsor ID
- PHOS-ISTOS / 2015_79
- Conditions
- Keratosis, Actinic
- Keywords
- PDT, Methyl Aminolevulinate, light emitting textile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- European Commission, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Sep 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the efficacy and tolerance of a new photodynamic therapy device (PHOS-ISTOS) with the conventional PDT device (Aktilite®) for the treatment of actinic keratosis of the scalp
Detailed description
The study is an intraindividual comparison of two methods. The number of subjects to be enrolled is 47. Patients will receive both treatments in a single visit: A first period of 2.5 hours of illumination with Phos-Istos device followed by a continuous red light spectrum (between 7 and 10 minutes) with Aktilite® after an appropriate incubation of MAL (methyl aminolevulinate). Patients will complete a pain assessment scale after receiving both treatments. 3 follow-up visits will be then scheduled
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Split Face intra individual comparison
| Arm | Type | Receives |
|---|---|---|
| Conventional PDT | Active comparator | Device: Aktilite® GaldermaAktilite® Galderma |
| PHOS ISTOS PDT | Experimental | Device: PHOS ISTOS PDTLight Emitting textile device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of minimum 10 previously untreated not pigmented, non-hyperkeratotic AK lesions of Grade I and II of the forehead and/or scalp (according to Olsen et Al. JAAD 1991, cf. REF 31) where other therapies are unacceptable or considered medically less appropriate with a symmetrical repartition on both side of the forehead and/or scalp. The diagnosis of AK will be determined upon clinical evaluation (i.e. visual inspection and palpation) by the investigator.
- No treatment for the AKs in the previous 30 days.
- Symmetrical areas in terms of number and severity of lesions. The axis of symmetry between the two areas will be defined by the investigator according to the distribution of lesions.
- The two areas to be treated should not be coalescing. A minimum distance of 10 mm is required between the lesions located on the 2 symmetrical areas. A minimum distance of 2 mm is required between the lesions on the same side.
- Minimum 5 lesions with similar dimensions at both symmetrical areas will be treated. If the number of lesions is >7, only 7 lesions on each side will be considered.
Key exclusion criteria (14 listed)
- Patients with porphyria.
- Patients immunosuppressed for idiopathic, disease specific or therapeutic reasons.
- Use of topical corticosteroids to lesional areas within 2 weeks before PDT.
- Patients receiving local treatment (including cryotherapy and curettage-electrocoagulation, any PDT treatment) in face / scalp area within the last 30 days.
- Patients receiving topical treatment (including imiquimod, 5-FU and diclofenac, Picato) in face / scalp area within the last 30 days.in
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aktilite® GaldermaAlso: Conventional PDTpreparation of the lesions, Metvixia application + occlusive dressing during 3 hours + illumination: 7 to 10 minutes | Device | Conventional PDT |
| PHOS ISTOS PDTpreparation of the lesions, Metvixia application + occlusive dressing during 30 minutes + illumination: 2.5 hours | Device | PHOS ISTOS PDT |
Primary outcome
Treated lesion response rate
Time frame: up to Month 6
Each treatment area will be counted, graded with Clinical grade of AK, mapped and photographed
5 secondary outcomes
Visual analog scale of pain
Time frame: at Day 1 and Day 7
Scale for clinical assessment of the subject's skin aspect
Time frame: at Month 3 and Month 6
Rate of patients with at least 75% of reduction of the lesions
Time frame: at Month 3 and Month 6
Dermatology Life Quality Index (DLQI )
Time frame: at day 1 , Day 7, Month 3 and Month 6
Satisfaction autoquestionnaire
Time frame: at Day 7, Month 3 and Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Derived from this study: PubMed 31025953Vignion-Dewalle AS, Abi Rached H, Thecua E, Lecomte F, Deleporte P, Behal H, Hommel T, Duhamel A, Szeimies RM, Mortier L, Mordon S. A New Light-Emitting, Fabric-Based Device for Photodynamic Therapy of Actinic Keratosis: Protocol for a Randomized, Controlled, Multicenter, Intra-Individual, Phase II Noninferiority Study (the Phosistos Study). JMIR Res Protoc. 2019 Apr 26;8(4):e12990. doi: 10.2196/12990.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Mortier, MD, PhD principal investigator
University Hospital, Lille
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aktilite® Galderma and PHOS ISTOS PDT in people with Keratosis, Actinic, run by University Hospital, Lille at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treated lesion response rate (time frame: up to Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03076892, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.