Protocol summary

Summary
The main purpose of this study is investigation of wound healing effect of topical dragons blood cream. This study is a randomized double blind placebo-controlled trial. 60 patients with skin tag lesions will be randomized in two parallel groups Which primary group will receive dragons blood cream and second group will receive placebo. Inclusion criteria: age 14 to 65 years, skin tag lesions that remove with cutting method, benign lesions, the patients without immunosuppressive diseases, the patients that don’t receive special drugs , the diameter of lesions should be 3-10 mm. Exclusion criteria: immunosuppressive diseases, pregnancy or breastfeeding. The surgery of lesions will be done in full thickness method by a dermatologist and lesions will cure with secondary intention. When the bleeding is stopped, dragons blood cream will be applied on wound and it will be dressed. Patients will cover the wound with dragons blood cream twice daily for 20 days .Patients will be visited on 3, 5, 7, 10,1 4, 20 days after surgery. The area of wound will be measured using transparent graph paper Sheets divided by 1 square millimeter. First day, area of wound is 100 percent and healing is 0 percent. Next days, area of wound will be measured. So wound healing is compared with the first day until healing will be 100 percent. Then total time of healing will be recorded for every wound.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201008224610N1
Registration date: 2011-10-27, 1390/08/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-10-27, 1390/08/05
Registrant information
Name
Foroogh Namjoyan
Name of organization / entity
School of pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8380
Email address
f.namjooyan@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for reseach, Jundishapur University of Medical sciences
Expected recruitment start date
2011-02-20, 1389/12/01
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical investigation of wound healing effect of topical dragons blood cream
Public title
Investigation of wound healing effect of topical Dragon's Blood cream
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 14 to 65 years, skin tag lesions that remove with cutting method; benign lesions; the patient without immunosuppressive diseases; the patients that don’t receive special drugs; the diameter of lesions should be 3-10 mm. Exclusion criteria: immunosuppressive diseases, pregnancy or breastfeeding.
Age
From 14 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Jundishapur University of medical Sciences
Street address
Jundishapur Medical University Campus
City
Ahvaz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
2256

Health conditions studied

1

Description of health condition studied
wound healing
ICD-10 code
T14.1
ICD-10 code description
Open wound of unspecified body region

Primary outcomes

1

Description
area of wound
Timepoint
1st, 3th, 5th, 7th, 14th, 20th days
Method of measurement
transparent graph paper

Secondary outcomes

empty

Intervention groups

1

Description
cover the wound area in treatment group with a layer of dragon's cream twice daily.
Category
Treatment - Drugs

2

Description
cover the wound area in placebo group with a layer of placebo cream twice daily.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dermatological center of Emam Khomeini hospital
Full name of responsible person
Dr. Zahra Beigom Moosavi
Street address
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jundishapur University of medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Vice chancellor for research, Jundishapur University of medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jundishapur University of medical Sciences
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
Jundishapur University of medical Sciences
Full name of responsible person
Foroogh Namjooyan
Position
Ph.D, Assistant Professor
Other areas of specialty/work
Street address
Pharmacognosy Department, School of Pharmacy, Jundishapur University of medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 1373 8380
Fax
+98 61 1373 8381
Email
namjoyan@yahoo.com , Forooghnamjooyan@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jundishapur University of medical Sciences
Full name of responsible person
Foroogh Namjooyan
Position
Ph.D
Other areas of specialty/work
Street address
Pharmacognosy department, School of pharmacy, Jundishapur University of medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 1373 8380
Fax
Email
Namjoyan@yahoo.com , forooghnamjooyan@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Jundishapur University of medical Sciences
Full name of responsible person
Fatemeh Saffari
Position
student
Other areas of specialty/work
Street address
Pharmacognosy Department, School of Pharmacy, Jundishapur University of medical Sciences
City
Ahvaz
Postal code
Phone
Fax
Email
Web page address

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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