comparing the additive effect of topical pentoxifylline and phototherapy versus topical tacrolimus and phototherapy inpateints with vitiligo
Design
Patients who were included in the study were treated with NBUVB phototherapy and 70 lesions in equal and equal groups were considered symmetrically and randomistically in different anatomical regions. The lesions are then randomly treated with pentoxifylline and tacrolimus. Creams are applied twice a day. The contents of both drugs are identical and encoded. The code list is available to the manufacturer of the drug and only two drug groups are divided into the formulator.
VASI criteria and quantitative measurements of melanin and erythema of lesion with Dermukach were used to evaluate patients. In this study, the patients were evaluated three times by the researcher: 1- before the intervention 2- one month after the intervention 3- 3 months after the intervention.
Settings and conduct
Dermatology Clinic of the Shahid Faghihi Hospital, 70 vitiligo lesions were treated in two groups of both intervention and control with two tacrolimus and pentoxifylline triple blinds.
Participants/Inclusion and exclusion criteria
Patients with vitiligo over 14 years of age who have two vitiligo lesions are symmetrical and treated with NBUVB. Patients have not received systemic or topical medication for the treatment of Vigiloga during the past three months. Sensitivity to the two drugs used, pregnant and lactating women, patients with uncontrolled systemic disorders have been excluded.
Intervention groups
In the intervention group, the vitiligo lesion was 10% Pentoxifylline cream and 0.1% Tacrolimus cream was in control group.
Main outcome variables
Qualitative measure with VASI score and quantitative measurement with dermocatch tool
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120909010795N3
Registration date:2019-05-09, 1398/02/19
Registration timing:retrospective
Last update:2019-05-09, 1398/02/19
Update count:0
Registration date
2019-05-09, 1398/02/19
Registrant information
Name
Nasrin Saki
Name of organization / entity
Dermatology Department,Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 19049
Email address
sakina@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2017-08-23, 1396/06/01
Actual recruitment end date
2018-02-20, 1396/12/01
Trial completion date
2018-03-16, 1396/12/25
Scientific title
comparing the additive effect of topical pentoxifylline and phototherapy versus topical tacrolimus and phototherapy inpateints with vitiligo
Public title
Comparison of pentoxifylline and tacrolimus in the treatment of vitiligo patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with vitiligo (with clinical diagnosis and Wood's Lamp)
Patients with at least two relatively and bilateral lesion.
Patients undergoing treatment with NBUVB
Residence in Shiraz, in case of non-residence in Shiraz, may attend meetings required for a visit.
Having the ability to understand Persian language written consent to participate in the study.
Exclusion criteria:
Over the last three months, they have received topical vitiligo medication
Unwillingness to receive local interventions
Age
From 14 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
35
More than 1 sample in each individual
Number of samples in each individual:
2
Two similar lesions and symmetric lesions on both sides of the body in each patient
Actual sample size reached:
35
More than 1 sample in each individual
Actual sample size in each individual:
2
Two similar lesions and symmetric lesions on both sides of the body in each patient
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization tool, random number table
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients were enrolled with informed consent. The two drugs used in patients were in the same boxes. The drugs were marked with a code and they had the same shape. The prescriber was not aware of the drug encoding. For each patient, two lesions have been selected at two points in his body. patients did not know the coding of drugs. The treating physician who visited them in three steps did not know the encoding of drugs. The analyzer did not know the coding of the drugs. The author of the draft article did not know the encoding of drugs. The drug code was only available to the manufacturer of the drug, which has been available to other researchers after writing the draft article.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
shahid faghihi hospital, zand Blvd
City
shiraz
Province
Fars
Postal code
71348846114
Approval date
2017-08-23, 1396/06/01
Ethics committee reference number
IR.SUMS.MED.REC.1397.296
Health conditions studied
1
Description of health condition studied
vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
pigmentation
Timepoint
At the beginning of the study, one month and three months after starting treatment
Method of measurement
Qualitative measure with VASI score and quantitative measurement with dermocatch tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 35 vitiligo lesions have been treated locally with pentoxifylline in patients with NBUVB treated light therapy. Pentoxifylline was 10% in the form of a topical cream. This drug was made by the Faculty of Pharmacy of Shiraz University of Medical Sciences. The method of making drug was incorporation on the basis of cold cream .
Category
Treatment - Drugs
2
Description
Control group: 35 Vitiligo lesions have been treated topically with tacrolimus in patients with NBUVB treated light therapy. Tacrolimus is a topical cream of 0.1%. This drug is made by aburaihan pharmaceutical Co, a brand name of moduproc.