Assessment of a topical nano formulation of tretinoin effect in the treatment of Hand-foot syndrome as a side effect of chemotherapeutic agents (Capecitabine, Fluorouracil, Doxorubicin, Docetaxel)
The aim of this study is to suggest a proper topical nano formulation of tretinoin to improve Hand-foot syndrome symptoms in patients who received chemotherapy agents like: Capecitabine, Fluorouracil and Docetaxel. 30 cancer patients between 30-80 years old of both sexes with hand-foot syndrome induced by chemotherapy agents are recruited. Written informed consent was achieved from all the patients. Patients are excluded from the investigation in the case of skin infection, sensitivity to our formulation and unwillingness to take apart in the study. This study was designed as a double-blind, placebo-controlled, parallel and randomized clinical trial. Patients were entered in two groups randomly. Group A were patients who applied a thin layer of topical drug on their hands and feet once or twice daily. Group B were patients who received topical placebo with similar regimen. We helped Common Terminology Criteria for Adverse Events (CTCAE) for grading syndrome based on the severity of symptoms. The beginning and the ending day of study, the severity of lesions are checked, photographed and questionnaire is completed and changes are investigated, also each patient was followed every 14 days. The treatment period varied from one to three months based on the patient’s response.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201707163106N33
Registration date:2017-10-10, 1396/07/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-10, 1396/07/18
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
by student
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of a topical nano formulation of tretinoin effect in the treatment of Hand-foot syndrome as a side effect of chemotherapeutic agents (Capecitabine, Fluorouracil, Doxorubicin, Docetaxel)
Public title
Assessment of a topical retinoid effect in the treatment of a cutaneous side effect of chemotherapeutic agents
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with hand-foot syndrome; Patients who 30 to 80 years old. Exclusion criteria: Skin infections; Skin cancer; Sensitivity to compounds of formula; Patient dissatisfaction
Age
From 30 years old to 80 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University Of Pharmaceutical Sciences Branch
Street address
Yakhchal Avenue، Qolhak، Dotor Shariati Avenue، Tehran
City
Tehran
Postal code
Approval date
2016-05-17, 1395/02/28
Ethics committee reference number
IR.IAU.PS.REC.1395.10
Health conditions studied
1
Description of health condition studied
hand-foot syndrome
ICD-10 code
L27.1
ICD-10 code description
localized skin eruption due to drugs and medicaments
Primary outcomes
1
Description
Severity of hand-foot syndrome
Timepoint
Beginning of the study, every 14 days, End of the study
Method of measurement
Common Terminology Criteria for Adverse Events
Secondary outcomes
1
Description
Skin Sensitivity
Timepoint
Beginning of the study, every 14 days, End of the study
Method of measurement
Observational
Intervention groups
1
Description
The topical nano-tretinoin will be administrated to hands and feet of patients once or twice daily for 1 to 3 months Based on patients' response.
Category
Treatment - Drugs
2
Description
The topical placebo will be administrated to hands and feet of patients once or twice daily for 1 to 3 months Based on patients' response.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Booali haspital
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Street address
City
Tehran
3
Recruitment center
Name of recruitment center
Rasoole Akram hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pharmaceutical Sciences branch, Islamic Azad University(a part of hanieh pourmousavi's PharmD thesis
Full name of responsible person
Dr.Seyd Jalaledin Hosseini Ghoncheh
Street address
Islamic Azad University Of Pharmaceutical Sciences Branch، Yakhchal avenue، Dotor Shariati avenue، Tehran
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmaceutical Sciences branch, Islamic Azad University(a part of hanieh pourmousavi's PharmD thesis
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
islamic Azad University Of Pharmaceutical Sciences Branch
Full name of responsible person
Hanieh pourmousavi
Position
student of pharmacy
Other areas of specialty/work
Street address
pharmaceutical sciences branch of islamic azad university، Yakhchal avenue، Doctor Shariati Avenue، Tehran
City
tehran
Postal code
Phone
+98 21 2264 0051
Fax
Email
hani_pmousavi@yahoo.com mehdirj@aol.co.uk
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Of Pharmaceutical Sciences Branch
Full name of responsible person
Dr mehdi Rajabi
Position
Ph.D. in Clinical Pharmacy
Other areas of specialty/work
Street address
Islamic Azad University Of Pharmaceutical Sciences Branch، Yakhchal avenue، Dotor Shariati avenue، Tehran
City
tehran
Postal code
Phone
+98 21 2264 0056
Fax
Email
mehdirj@aol.co.uk
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Of Pharmaceutical Science Branch
Full name of responsible person
Hanieh pourmousavi
Position
pharmacy student
Other areas of specialty/work
Street address
pharmaceutical sciences branch of islamic azad university، Yakhchal avenue، Doctor Shariati Avenue، Tehran
City
tehran
Postal code
Phone
+98 21 2264 0056
Fax
Email
hani_pmousavi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)