Comparison of intralesional vitamin D with intralesional triamcinolone acetonide in the treatment of keloids
Design
A clinical trial with a control group, with parallel groups, without blinding, simple randomization, phase 3 on 26 patients, rand function of Excel software is used for randomization.
Settings and conduct
Patients referred to the dermatology clinic of Imam Khomeini Hospital in Ahvaz
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness and cooperation to participate in the study; both genders and with the age of 18 to 60 years; all patients have two or more keloids; the duration of lesions is less than 5 years and they have not been treated so far; keloids with sizes different maximum 5 cm and in different parts of the body. Exclusion criteria: unwillingness to participate in the study; keloids in the face area; active infection in or near the keloid site; pregnant or lactating patients; People with underlying diseases such as diabetes; mental illness; cancer and heart disease
Intervention groups
Case group: Intralesional injection of vitamin D ampoule 300,000 units with a dose of 0.2 ml per 1 cm of the lesion. Maximum one milliliter of vitamin D is injected in each lesion. Treatment sessions are once every 3 weeks and the treatment lasts up to The flattening of the scar continues; an average of 6 sessions is considered as the duration of the patient's treatment). In the control group, triamcinolone is injected into the lesion with a concentration of 40 mg per milliliter in a maximum of six sessions, a maximum of one per lesion. ml is injected, the injection intervals in this treatment are done every 3 weeks.
Main outcome variables
Keloid size, grading based on Vancouver scar scale(vss) and complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220902055857N1
Registration date:2022-09-07, 1401/06/16
Registration timing:prospective
Last update:2022-09-07, 1401/06/16
Update count:0
Registration date
2022-09-07, 1401/06/16
Registrant information
Name
Sedigheh Sananzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 0000
Email address
sananzadeh.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intralesional vitamin D with intralesional triamcinolone acetonide in the treatment of keloids
Public title
Effect of intralesional vitamin D in treatment of keloid
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness and cooperation to participate in the study
All patients with two or more keloids
The duration of lesions should be less than 5 years and they have not been treated yet
keloids with different sizes up to 5 cm and in different parts of the body
Exclusion criteria:
keloid on face
active infection in or near the keloid site
pregnant or lactating patients
patients with underlying diseases such as diabetes, mental illness, cancer and heart disease
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
26
More than 1 sample in each individual
Number of samples in each individual:
2
Every patient has two keloids
Randomization (investigator's opinion)
Randomized
Randomization description
The simple random assignment method is that for patients with one lesion, odd numbers are given to the intervention group (new treatment) and even numbers are given to the control group (common treatment).Then, according to the number of the studied sample, the relevant numbers are extracted using the computer, each number is written on a card and placed in an envelope, and the envelopes are sealed, and the patient's number is written on each envelope, and the first patient in The study is registered and entered into the study, the envelope related to patient number 1 and envelope number 2 will be given to the second patient. In the same way, this work will continue until the end of the sample size of the study. In order to maintain randomization, the person who prepares the envelopes with The person who registers the patients and provides the envelopes to the patients should be different. For patients who have two lesions, one envelope is given for the right side lesions and the highest lesion.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of JundiShapur Ahvaz University of Medical Sciences
Street address
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences; Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Approval date
2022-06-21, 1401/03/31
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1401.063
Health conditions studied
1
Description of health condition studied
Keloid
ICD-10 code
L91.0
ICD-10 code description
Hypertrophic scar
Primary outcomes
1
Description
Keloid score in the Vancouver Scar scale
Timepoint
Vancouver scar scale upon arrival, 3, 6, 9, 12, 15 weeks after each injection session until the lesion is completely flattened or up to 6 sessions
Method of measurement
Vancouver scar scale
Secondary outcomes
1
Description
Patient satisfaction from treatment
Timepoint
End of treatment
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: Intralesional injection of vitamin D ampoule from Caspian Pharmaceutical Company will be prescribed to patients. Vitamin D ampoule 300,000 units will be injected at a dose of 0.2 ml per 1 cm of the lesion. A maximum of one milliliter of vitamin D will be injected into each lesion. The intervals of the treatment sessions are once every 3 weeks and the treatment continues until the scar flattens; an average of 6 sessions is considered the duration of the patient's treatment.
Category
Treatment - Drugs
2
Description
Control group: Intralesional injection of triamcinolone from EXIR with a concentration of 40 mg per milliliter is used in a maximum of six sessions, a maximum of one milliliter is injected in each lesion, the injection intervals in this treatment are also done once every 3 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ahvaz
Full name of responsible person
Nader Pazyar
Street address
Imam khomeini Medicinal Academic Center, Azadegan Ave
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Email
sananzadeh.s@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Ground floor, Vice chanceller of research, Ahvaz Jundishapour University of Medical Sciences, Daneshgahi Town, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?