Safety and Efficacy Study of Topical Methyaminlevulinate (MAL) in Subjects With Facial Acne
29 janvier 2009 mis à jour par: Photocure
A Study of Safety and Efficacy of Topical Methylaminolevulinate 80mg/g With and Without Occlusion Followed by Red Light Exposure in Subjects With Facial Acne
A study of safety and efficacy of topical methyaminlevulinate 80mg/g with and without occlusion followed by red light exposure in subjects with facial acne.
Aperçu de l'étude
Description détaillée
Photocure ASA has developed a cream formulation containing methyl aminolevulinate (MAL), an ester of ALA. There is extensive experience with the safety of MAL-PDT in humans.
This study will assess safety and efficacy of four treatments with methylaminolevulinate (MAL) at 80 mg/g performed with and without occlusion and followed by red light exposure 90 minutes later in subjects with facial acne vulgaris. Subjects will be randomized to one of two groups of 20 subjects: Group 1 will receive 25 J/cm2 of red light (45 mW/cm2) and group 2 will receive 37 J/cm2 of red light (90 mW/cm2). For each subject one side of the face will be randomized to receive MAL for 90 minutes without occlusion and the other side of the face will receive MAL for 90 minutes with occlusion.
Type d'étude
Interventionnel
Inscription (Réel)
44
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Quebec
-
Laval, Quebec, Canada, H7S 2C6
- Innovaderm Research Inc
-
Montreal, Quebec, Canada, H2K 4L5
- Innovaderm Research Inc.
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Subject willing to use an adequate contraceptive method or is surgically sterile, post menopausal, abstinent or with a same-sex partner. Adequate means of contraception include; IUD in use 30 days prior to day 0, barrier methods and spermicide in use atleast 14 days prior to day 0 or oral contraceptive in use for at least 6 months prior to day 0
- Age 18 or older
- Capable of giving informed consent
- Diagnosis of acne vulgaris on the face with at least 10 inflammatory lesions on both sides of the face at screening and day 0
- Global acne severity assessment score ≥ 3 at the screening and day 0 visit.
Exclusion Criteria:
- Allergy to methylaminolevulinate or any component of the vehicle
- Acne fulminans or conglobata on the face
- Clinical significant sensitivity to visible light, porphyria or porphyrin sensitivity
- Use of any topical treatment for acne on the face within the previous 2 weeks before day 0
- Any use of systemic antibiotics within 1 month prior to day 0 or use of isotretinoin within 1 year prior to Day 0
- Exposure to ultraviolet radiation (UVB phototherapy, sun tanning salons) within 4 weeks of Day 0
- Use of any investigational drug within 4 weeks of Day 0
- Alcoholism or drug abuse in the past year
- Any unstable or serious medical condition at the discretion of the investigator
- Current pregnancy or lactation
- Use of hormonal contraceptives solely for control of acne
- Current use of oral contraceptives (unless subject is on a stable dose e.i. at least six months of treatment prior Day 0), testosterone or any other systemic hormonal treatment
- Any serious dermatological disorder, including malignancies that would either put the subject at risk or interfere with efficacy or safety evaluations
- Fitzpatrick phototype V or VI (inadequate penetration of red light in dark skin subjects)
- Subjects with extensive facial hair (e.g. beard) that would either impair red light exposure or interfere with lesion evaluation.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 25 J/cm2, with occlusion on right side
Subjects will receive MAL cream in a thin layer on both sides of the face (except nose and peri-ocular area) at a concentration of 80 mg/g).
Occlusion will be applied to one half of the face.
After an incubation time of 90 minutes both sides of the face will be exposed to either 25 J/cm2 of red light starting with the occluded side first.
|
80 mg/g cream one administration with incubation for 90 minutes
|
|
Comparateur actif: 37 J/cm2, with occlusion on right side
Subjects will receive MAL cream in a thin layer on both sides of the face (except nose and peri-ocular area) at a concentration of 80 mg/g).
Occlusion will be applied to one half of the face.
After an incubation time of 90 minutes both sides of the face will be exposed to 37 J/cm2 of red light starting with the occluded side first.
|
80 mg/g cream one administration with incubation for 90 minutes
|
|
Comparateur actif: 25 J/cm2 , with occlusion on left side
Subjects will receive MAL cream in a thin layer on both sides of the face (except nose and peri-ocular area) at a concentration of 80 mg/g).
Occlusion will be applied to one half of the face.
After an incubation time of 90 minutes both sides of the face will be exposed to either 25 J/cm2 of red light starting with the occluded side first.
|
80 mg/g cream one administration with incubation for 90 minutes
|
|
Comparateur actif: 37 J/cm2 , with occlusion on left side
Subjects will receive MAL cream in a thin layer on both sides of the face (except nose and peri-ocular area) at a concentration of 80 mg/g).
Occlusion will be applied to one half of the face.
After an incubation time of 90 minutes both sides of the face will be exposed to 37 J/cm2 of red light starting with the occluded side first.
|
80 mg/g cream one administration with incubation for 90 minutes
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
To compare the number of inflammatory acne lesions according to time on the side with occlusion and the side without occlusion for subjects with facial acne vulgaris exposed to 25 J/cm2 and 37 J/cm2 of red light.
Délai: 4 and 12 weeks after last PDT session.
|
4 and 12 weeks after last PDT session.
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Exposed to 25 J/cm2 and 37 J/cm2 of red light and with and withut occlusion :-Compare number of non-inflammatory acne lesions. -Safety assesment of MAL-PDT. -Evaluate PAP photobleaching.
Délai: At each treatment visit and 2 and 7 days after first PDT treatment visit.
|
At each treatment visit and 2 and 7 days after first PDT treatment visit.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Robert Bissonnette, MD MSC FRCPC, Innovaderm Research Inc.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juillet 2007
Achèvement primaire (Réel)
1 juillet 2008
Achèvement de l'étude (Réel)
1 juillet 2008
Dates d'inscription aux études
Première soumission
29 janvier 2009
Première soumission répondant aux critères de contrôle qualité
29 janvier 2009
Première publication (Estimation)
30 janvier 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
30 janvier 2009
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 janvier 2009
Dernière vérification
1 janvier 2009
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- INNO-6005
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