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Identification of Maximum Tolerated Dose for topical form of Carbon Selenium Complex in healthy volunteers

Protocol summary

Summary
Carbon Selenium Complex (CSeC), as a topical drug, has been investigated as an innovation in prevention and treatment of complications of burn. In this study, we will test different doses CSeC to find appropriate dosage of the drug for phase II, III and IV clinical trial on the treatment of heat burn injuries. This study is designed as a phase I clinical trial, without control group and as an open label study in two steps from 21st of April till 21st of June. 15 healthy volunteers will contribute in 5 equivalent groups after signing informed consent. Physical examination and laboratory tests will be performed for all participants to rule out underlying diseases or any other serious cutaneous diseases. All participants receive equal dose of CSeC and the dosage of the drug will increase from group 1 to 5. In the first step, group 1, 2, and 3 will begin the study and group 4 and 5 will remain for the next step. Hydration, PH, pigmentation, sebum, trans-epidermal water loss, erythema, and side effects will be measured as main outcomes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138811253267N1
Registration date: 2010-06-12, 1389/03/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-06-12, 1389/03/22
Registrant information
Name
Sedigheh Madani
Name of organization / entity
Parsroos
Country
Iran (Islamic Republic of)
Phone
+98 21 8837 0763
Email address
s.madani@parsroos.com
Recruitment status
Recruitment complete
Funding source
parsroos company
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2010-07-21, 1389/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Identification of Maximum Tolerated Dose for topical form of Carbon Selenium Complex in healthy volunteers
Public title
phase I clinical trial of topical Carbon Selenium Complex
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: signing informed consent, no extremities edema or other abnormal signs, normal lab test including: Liver function tests ( AST, ALT, Alkaline Phosphatase, and Bilirubin); serum creatinine; Random blood sugar level
Age
From 18 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences
Street address
Pharmaceutical Sciences Research Center,Tehran University of Medical Sciences,Enghelab Square, Tehran
City
Tehran
Postal code
1417614411
Approval date
2009-11-04, 1388/08/13
Ethics committee reference number
88/ص/425/190

Health conditions studied

1

Description of health condition studied
heat burn injury
ICD-10 code
T20, T21,
ICD-10 code description
Burns and corrosions of external body surface, specified by site

Primary outcomes

1

Description
Sebum measurment
Timepoint
at first session (before and 30 min after application), at last session
Method of measurement
by using C.K tool(courage-khazaka)

2

Description
hydration
Timepoint
at first session (before and 30 min after application), at last session
Method of measurement
by using C.K tool(courage-khazaka)

3

Description
PH
Timepoint
at first session (before and 30 min after application), at last session
Method of measurement
by using C.K tool(courage-khazaka)

4

Description
pigmentation
Timepoint
at first session (before and 30 min after application), at last session
Method of measurement
by using C.K tool(courage-khazaka)

5

Description
erythema
Timepoint
at first session (before and 30 min after application), at last session
Method of measurement
by using C.K tool(courage-khazaka)

6

Description
trans epidermal water loss (TEWL)
Timepoint
at first session (before and 30 min after application), at last session
Method of measurement
by using C.K tool(courage-khazaka)

Secondary outcomes

empty

Intervention groups

1

Description
Carbn Selenium Complex oinment will be applied on anterion of forearm in a 5*5 cm surface daily for 14 days. No derressing will be needed and no washing for 6 hours will be required.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Dr. Alireza Firooz
Street address
Center for Research and Training in Skin Disease and Leprosy, Tehran University of Medical Sciences. 79 Taleghani Ave ,Tehran , 14166, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Parsroos Company
Full name of responsible person
Dr Kamran Motadedi
Street address
No 568,13th Alley, Hormozan St., Shhrsk-e-gharb, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Parsroos Company
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
Center for Research and Training in Skin Diseases and Leprosy
Full name of responsible person
Alireza Firooz
Position
Dermatologist, Associate Professor
Other areas of specialty/work
Street address
79 Taleghani Avenue, Tehran university of medical science, Center for Research and Training in Skin Diseases and Leprosy, Tehran, 14166, Iran
City
Tehran
Postal code
14155-6383
Phone
+98 21 8897 8190
Fax
+98 21 8896 3804
Email
alifiruz@yahoo.com; firozali@sina.tums.ac.ir
Web page address
http://crtsdl.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Center for Research and Training in Skin Diseases and Leprosy
Full name of responsible person
Alireza Firooz
Position
Dermatologist,Associate Professor
Other areas of specialty/work
Street address
79 Taleghani Avenue, Tehran university of medical science, Center for Research and Training in Skin Diseases and Leprosy, Tehran, 14166, Iran
City
Tehran
Postal code
14155-6383
Phone
+98 21 8897 8190
Fax
+98 21 8896 3804
Email
alifiruz@yahoo.com; firozali@sina.tums.ac.ir
Web page address
http://crtsdl.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
ParsRoos company
Full name of responsible person
Seyedeh Sedigheh Madani
Position
Medical doctor
Other areas of specialty/work
Street address
No.538, 13th alley,hormozan street, shahrak-e-gharb, Tehran, Iran
City
Tehran
Postal code
1466793143
Phone
+98 21 8837 0763
Fax
+98 21 8837 0763
Email
sedigheh_madani@yahoo.com
Web page address
www.parsroos.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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