Evaluation of Non-inferiority and Tolerability of the Device PHOS-ISTOS

Keratosis, Actinic Clinical Trial

— PHOS-ISTOS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03076892
• Other study ID #: 2015_79
• Secondary ID: 2016-A00010-51
• Status: Completed
• Phase: N/A
• First received: March 7, 2017
• Last updated: November 13, 2017
• Start date: September 2016
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Keratosis
• Keratosis, Actinic

Intervention

Device:
• Aktilite® Galderma
preparation of the lesions, Metvixia application + occlusive dressing during 3 hours + illumination: 7 to 10 minutes
• PHOS ISTOS PDT
preparation of the lesions, Metvixia application + occlusive dressing during 30 minutes + illumination: 2.5 hours

Locations

Country	Name	City	State
France	CHRU, Hôpital Claude Huriez	Lille
Germany	Klinikum Vest Gmbh	Recklinghausen

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	European Commission, Institut National de la Santé Et de la Recherche Médicale, France

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treated lesion response rate	Each treatment area will be counted, graded with Clinical grade of AK, mapped and photographed	up to Month 6
Secondary	Visual analog scale of pain	measure the pain and local tolerance graduation range 0 to 10.	at Day 1 and Day 7
Secondary	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	at Month 3 and Month 6
Secondary	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	at Month 3 and Month 6
Secondary	Dermatology Life Quality Index (DLQI )	The questionnaire of 10 questions is completed by the patient to evaluate his quality of life	at day 1 , Day 7, Month 3 and Month 6
Secondary	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	at Day 7, Month 3 and Month 6