Protocol summary
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Study aim
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The main goal of this study is to compare the effectiveness of nanofibers and creams containing 5% 5-fluorouracil in the treatment of Actinic keratosis. Also, the effect of Rosemary extract on the treatment is identified.
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Design
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parallel-group randomized controlled blinded phase 2 trial with 15 patients and 45 lesions
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Settings and conduct
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A non-blinded dermatologist evaluates the patients in Sedighe Tahere hospital before treatment, reaching the clinical diagnosis of actinic keratosis. The dermatologist determines lesions and records the primary photographic images. The treatment period takes 4 weeks.
The same dermatologist evaluates the patients 2 weeks after treatment and verifies the presence of adverse effects. The dermatologist also records the new photographic images and evaluates the improvement of the lesions.
Then, a blinded dermatologist evaluates the photographs and rates the improvement of the lesions.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Clinical diagnosis of actinic keratosis, At least 18 years old, Willing to participate in the study
Exclusion criteria:
Previous history of allergy to formulation ingredients, patients with lip lesions, pregnant and breastfeeding mothers, taking immunosuppressive drugs, cytotoxic drugs, and/or systemic corticosteroids, Use of any drugs for the treatment of lesions over the 4 passed weeks
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Intervention groups
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Control group: Patients take 5% 5-fluorouracil cream. They take the cream every night for 4 weeks.
Intervention group 1: Patients take the nanofibers containing 5% 5-fluorouracil. They take nanofibers every night for 4 weeks.
Intervention group 2: Patients take the nanofibers containing 5% 5-fluorouracil and 5% standardized Rosemary extract. They take nanofibers every night for 4 weeks.
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Main outcome variables
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The investigator global improvement score
General information
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Reason for update
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Because of the lack of primary predicted time for recruitment and conditions caused by Coronavirus that occurred to the reduction of patient visits, we should increase the recruitment time and decrease the sample size.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210118050067N1
Registration date:
2021-02-16, 1399/11/28
Registration timing:
prospective
Last update:
2021-07-09, 1400/04/18
Update count:
1
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Registration date
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2021-02-16, 1399/11/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-02-19, 1399/12/01
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Expected recruitment end date
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2022-07-23, 1401/05/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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A Comparative study of the effect of nanofibers containing 5% 5-Fluorouracil and rosemary extract and nanofibers containing 5% 5-Fluorouracil and 5% 5-Fluorouracil cream on Actinic Keratosis Lesions Treatment
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Public title
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effect of 5-fu and rosemary extract polymeric wound dressing
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Clinical diagnosis of actinic keratosis
at least 18 years old
consent of the individual to participate in the study
Exclusion criteria:
Previous history of allergy to formulation ingredients
pregnant or lactating mothers
patients on immunosuppressive, immunomodulatory, cytotoxic, and systemic steroid drugs
patients who received treatment for their lesions in the 4 weeks preceding the study
patients with lip lesions (because of prevention of changing into Squamous cell carcinoma)
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Age
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From 18 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
3
At least 3 Actinic Keratosis lesions
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization with the table of random number
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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A non-blinded dermatologist (investigator) evaluates the patients before treatment, reaching the clinical diagnosis of actinic keratosis. The dermatologist determines lesions and their location through the photographic image.
The same dermatologist evaluates the patients 2 weeks after treatment and verify the presence of adverse effects. The dermatologist also records new photographic images (under the same conditions of light and distance that the first ones were taken) evaluating the improvement of the lesions according to the Investigator Global Improvement Score and the patient’s degree of satisfaction through the visual analog scale Score. A blinded dermatologist evaluate the photographs and rate the improvement of the lesions through the Investigator Global Improvement Score.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-12-09, 1399/09/19
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1399.619
Health conditions studied
1
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Description of health condition studied
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Actinic keratosis
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ICD-10 code
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L57.0
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ICD-10 code description
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Actinic keratosis
Primary outcomes
1
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Description
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Treatment of cutaneous lesions
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Timepoint
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at the beginning and after 6 weeks
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Method of measurement
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Global improvement score
2
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Description
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Patient satisfaction
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Timepoint
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6 weeks after starting the use of nanofibers and Fluorouracil cream
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Method of measurement
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Visual Analogue Scale Score
Secondary outcomes
1
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Description
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Adverse effects
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Timepoint
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6 weeks after starting the use of nanofibers and Fluorouracil cream
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Method of measurement
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Ask the patient and Physical examination
Intervention groups
1
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Description
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Control group: Patients take 5% 5-fluorouracil cream from Meda Co. They take the cream every night until the next morning for 4 weeks.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Patients take the Polyvinyl alcohol nanofibers containing 5% 5-fluorouracil. They take nanofibers every night until the next morning for 4 weeks.
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Category
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Treatment - Drugs
3
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Description
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Intervention group: Patients take the Polyvinyl alcohol nanofibers containing 5% 5-fluorouracil and 5% standardized Rosemary extract. They take nanofibers every night until the next morning for 4 weeks.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available