Formulation of a topical gel containing Lawsonia inermis and Crocin and evaluation its effects on preventing radiation-induced dermatitis in breast cancer patients: A randomized double-blinded placebo-controlled trial.
Determining the effectiveness of gel containing Henna and Crocin extract in the prevention of radiotherapy-induced dermatitis.
Design
This study is a clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3, which is performed on 50 patients, using RAND function of Excel software for randomization.
Settings and conduct
It is a double-blind randomized controlled clinical trial. Patients receive a uniform product so that neither the physician nor the patient is aware of the contents of the dosage form. Patients who receive radiotherapy will enter the study after obtaining written consent. Patients receive one of the hydrogel products containing Henna and Crocin extract or the basic hydrogel once a day for ten days. Patients are instructed to use only the products mentioned in the study and the necessary warnings about using other products. During and after treatment, every two days, the skin condition undergoing radiotherapy is evaluated for the severity of redness, dryness, itching, burning, and pain (score 0 to 4).
Participants/Inclusion and exclusion criteria
Breast cancer patients aged between 18 and 65 years.
Intervention groups
Daily consumption of Henna extract and Crocin or placebo.
Main outcome variables
The severity of erythema or redness, itching, burning or pain, dry skin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191106045356N20
Registration date:2024-08-15, 1403/05/25
Registration timing:prospective
Last update:2024-08-15, 1403/05/25
Update count:0
Registration date
2024-08-15, 1403/05/25
Registrant information
Name
Mohsen Zabihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3865
Email address
mzabihi100@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-21, 1403/05/31
Expected recruitment end date
2024-12-20, 1403/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulation of a topical gel containing Lawsonia inermis and Crocin and evaluation its effects on preventing radiation-induced dermatitis in breast cancer patients: A randomized double-blinded placebo-controlled trial.
Public title
Formulation of a topical gel containing Lawsonia inermis and Crocin and evaluation its effects on preventing radiation-induced dermatitis.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients starting radiotherapy
Patients aged 18 to 65 years
Exclusion criteria:
Patients with skin diseases
Allergy to henna or crocin
Severe systemic diseases such as uncontrolled diabetes, epilepsy, immune system defects, etc.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who meet the inclusion criteria are placed in one of two treatment groups with products containing Henna and Crocin (group A) or base hydrogel (group B). Randomization is performed based on the RAND () function of Excel software, and based on this, a table of random numbers is prepared, and patients are placed in groups A or B, respectively, in the rows of this table, and receive the product related to their group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Different groups of drugs are placed in uniform and coded containers, and the prescribing physician and the evaluator do not know the composition and content of each drug container.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Medicine, Shahid Sadougi University of Medical Sciences, Yazd
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916978447
Approval date
2024-07-06, 1403/04/16
Ethics committee reference number
IR.SSU.MEDICINE.REC.1403.095
Health conditions studied
1
Description of health condition studied
Dermatitis
ICD-10 code
L30.9
ICD-10 code description
Dermatitis, unspecified
Primary outcomes
1
Description
Severity of erythema or redness
Timepoint
During and after treatment, every ten days, the skin condition undergoing radiotherapy is evaluated for the severity of redness, dryness, itching, burning and pain.
Method of measurement
Scoring erythema or redness using a questionnaire
2
Description
Severity of itching
Timepoint
During and after treatment, every ten days, the skin condition undergoing radiotherapy is evaluated for the severity of redness, dryness, itching, burning and pain.
Method of measurement
Scoring itching using a questionnaire
3
Description
Severity of pain
Timepoint
During and after treatment, every ten days, the skin condition undergoing radiotherapy is evaluated for the severity of redness, dryness, itching, burning and pain.
Method of measurement
Scoring pain using a questionnaire
4
Description
Skin dryness score
Timepoint
During and after treatment, every ten days, the skin condition undergoing radiotherapy is evaluated for the severity of redness, dryness, itching, burning and pain.
Method of measurement
Scoring skin dryness using a questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: It includes 25 patients referred to the radiotherapy center who meet the inclusion criteria, whose order and type of intervention is random based on the RND () function of Excel software. Patients in the intervention group use a hydrogel containing Henna and Crocin extract prepared once a day before radiotherapy in the Faculty of Pharmacy of Shahid Sadoughi University of Medical Sciences in Yazd. After starting treatment, the condition of the lesion is evaluated for loss of epidermis, redness, dryness, itching, burning, and pain (score 0 to 4).
Category
Treatment - Drugs
2
Description
Control group: It includes 25 patients referred to the radiotherapy center who meet the inclusion criteria, whose order and type of intervention is random based on the RAND() function of Excel software. Patients in the control group use a hydrogel base prepared in the Faculty of Pharmacy of Shahid Sadoughi University of Medical Sciences in Yazd, once a day before radiotherapy. After starting treatment, the condition of the lesion is evaluated for loss of epidermis, redness, dryness, itching, burning, and pain (score 0 to 4).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiotherapy Center of Shahid Ramezanzadeh Yazd
Full name of responsible person
Dr. Mohammad Reza Lotfaliani
Street address
Shahid Motahari St.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3725 1176
Email
Lotf726@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Mirzaie
Street address
Bahonar sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Lotfaliani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
Lotf726@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Lotfaliani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
Lotf726@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Lotfaliani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
Lotf726@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available