Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507644
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Methyl Aminolevulinate 8 and 16 Incubated by 1 and 3 for Actinic Keratoses Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Topical Application of Methyl Aminolevulinate 8 and 16 Mediated by Red Light and Incubation Time of 1 and 3 Hours in the Treatment of Actinic Keratoses on the Face A Double-Blind Randomized Controlled Clinical Protocol
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this protocol is to compare the efficacy of the topical application of MAL at concentrations of 8 and 16 mediated by red light as well as to evaluate the impact of different incubation times 1 or 3 hours in the treatment of actinic keratoses on the face with a 6-month follow-up This parallel-arm 6-month follow-up randomized controlled clinical trial will consist of 4 groups G1 - Control Group - MAL 16 irradiated with 643nm and 75Jcm² and 3-hour incubation time n36 G2 - MAL 16 and 1-hour incubation n36 G3 - MAL 8 - 3 hours n36 and G4 - MAL 8 - 1 hour n36 The researcher conducting the collection and the participant will be blinded to the interventions The primary outcome will be the complete remission of the lesion at 6 months Secondary outcomes will include treatment success 75 reduction in the initial number of lesions recurrence rate emergence of SCC incidence of adverse effects and improvement in skin texture wrinkles and pigmentation using a validated scale All outcomes will be assessed at 30 days 3 and 6 months Quality of life will be evaluated using the Actinic Keratosis Quality of Life questionnaire AKQoL at 6 months
Detailed Description:
The multifocality of actinic keratosis the unpredictability of lesion evolution with potential progression to squamous cell carcinoma SCC and the consequent risk of local extension and metastasis alongside the recent development of new therapies make the selection of a therapeutic regimen challenging The increasing incidence associated economic costs and impact on quality of life have fostered interest in studying protocols for treating this severe skin condition The topical application of 16 methyl aminolevulinate MAL is well-established in the literature for its local therapeutic effects and ease of application However the high cost of medication long incubation time and adverse effects such as itching and burning in some patients limit the dissemination of this treatment Studies are needed to test other protocols of this promising therapy to increase acceptance among patients and professionals Therefore the objective of this protocol is to compare the efficacy of the topical application of MAL at concentrations of 8 and 16 mediated by red light as well as to evaluate the impact of different incubation times 1 or 3 hours in the treatment of actinic keratoses on the face with a 6-month follow-up This parallel-arm 6-month follow-up randomized controlled clinical trial will consist of 4 groups G1 - Control Group - MAL 16 irradiated with 643nm and 75Jcm² and 3-hour incubation time n36 G2 - MAL 16 and 1-hour incubation n36 G3 - MAL 8 - 3 hours n36 and G4 - MAL 8 - 1 hour n36 The researcher conducting the collection and the participant will be blinded to the interventions The primary outcome will be the complete remission of the lesion at 6 months Secondary outcomes will include treatment success 75 reduction in the initial number of lesions recurrence rate emergence of SCC incidence of adverse effects and improvement in skin texture wrinkles and pigmentation using a validated scale All outcomes will be assessed at 30 days 3 and 6 months Quality of life will be assessed using the Actinic Keratosis Quality of Life questionnaire AKQoL at 6 months If data are normal they will be subjected to 3-way ANOVA and presented as means standard deviation SD Otherwise they will be presented as median and interquartile range and compared using the Kruskall-Wallis and Friedman tests Categorical variables will be evaluated with the chi-square test Fishers exact test or likelihood ratio test A p-value 005 will be considered significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None