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Trial registered on ANZCTR


Registration number
ACTRN12611001165976
Ethics application status
Approved
Date submitted
2/11/2011
Date registered
8/11/2011
Date last updated
8/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of the combination therapy of Pimecrolimus 1% cream and Mometazone cream with either agent alone in the treatment of childhood vitiligo
Scientific title
Efficacy of the combination therapy of Pimecrolimus 1% cream and Mometazone cream with either agent alone in the treatment of childhood vitiligo
Secondary ID [1] 273335 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitiligo 279080 0
Condition category
Condition code
Skin 279271 279271 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In each patient three lesions with approximately equal size, in the same anatomic location (limbs, trunk, sun exposed or covered areas) will be selected. Topical pimecrolimus cream 1% will be applied to the first lesion twice daily, topical mometazone furoat 0.1% ointment will be applied for the second lesion every night, and pimecrolimus cream 1% and topical mometazone ointment 0.1% will be applied to the third lesion twice daily for the first 5 days and the subsequent 2 days of the week at nights respectively. All three treatments are administered simultaneously over the same three month period (total treatment period 3 months) and after that patients will be followed up for another 3 months as well.
Intervention code [1] 283658 0
Treatment: Drugs
Comparator / control treatment
The patients’ lesions will be compared with his /her own ones, before and after the treatment protocol.
Control group
Active

Outcomes
Primary outcome [1] 279891 0
The size of the lesions will be determined and recorded via skin photography. An external observer who is unaware of the treatment protocols also will evaluate the lesions independently.
Timepoint [1] 279891 0
before starting the treatment protocol, at the end of 1, 2 and 3 months of treatment period and also at the end of 1, 2 and 3th month of follow up period.
Secondary outcome [1] 294700 0
The pigmentation of the lesions will be determined and recorded via skin photography. An external observer who is unaware of the treatment protocols also will evaluate the lesions independently.
Timepoint [1] 294700 0
before starting the treatment protocol, at the end of 1, 2 and 3 months of treatment period and also at the end of 1, 2 and 3th month of follow up period.

Eligibility
Key inclusion criteria
No history of any kind of treatments for vitiligo since 1 month of starting the study.
Minimum age
2 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The patients with uncontrolled systemic diseases, renal failure, autoimmune disorders, history of sensitivity to pimecrolimus cream and topical steroids/macrolides, and unstable vitiligo will be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3939 0
Iran, Islamic Republic Of
State/province [1] 3939 0
kerman

Funding & Sponsors
Funding source category [1] 284142 0
University
Name [1] 284142 0
Kerman Medical University
Address [1] 284142 0
Kerman medical university, Jomhori Eslami Avenue, Kerman,Kerman province, Iran
postal code: 7618747647
Country [1] 284142 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Kerman Medical University
Address
Kerman medical university, Jomhori Eslami Avenue, Kerman,Kerman province, Iran
postal code: 7618747647
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 269104 0
Hospital
Name [1] 269104 0
Afzalipour hospital
Address [1] 269104 0
Afzalipour hospital, Emam Khomeini High way, Kerman, Kerman province, Iran
postal code: 7616913888
Country [1] 269104 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272100 0
Ethical committe of Kerman medical University
Ethics committee address [1] 272100 0
Ethics committee country [1] 272100 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 272100 0
Approval date [1] 272100 0
Ethics approval number [1] 272100 0

Summary
Brief summary
Vitiligo is a common acquired pigmentation disorder with unknown cause that results in destruction of melanocyte cells. In 50% of cases the disease is started before twenty years of old that may lead to significant psycho-spiritual impairments in children.
There are various therapeutic options for the treatment of vitiligo, however, none of these treatments are quite effective and safe so far. The resistance to treatments, recurrence and therapeutic side effects are some of the complications that may happen with the current therapeutic options. All these treatment options have their own limitations due to the side effects and unsuitable therapeutic responses. So efforts to find new treatment options covering these pitfalls are still continued. Recently in some limited studies, topical immunomodulators (TIMS) in the calcineurin inhibitor family (such as topical tacrolimus and pimecrolimus) have been used for the treatment of vitiligo in children as safe and efficient therapeutic options. These are safe drugs but the problem of high cost has limited their use as a routine treatment. However, combination therapy of TIMS with other therapeutic modalities and drugs may result in increased efficacy, decreased side effects and cost of treatment and shortening the duration of treatment. In the current study, we decide to compare the therapeutic effects of single TIMS therapy, with combination therapy of mometazone ointment and pimecrolimus cream for the treatment of vitiligo in children. As literature explains combination of two drugs in form of “week day/weekend” regime has increased the therapeutic effects with little side effects in the treatment of some of the skin disorders such as psoriasis, so we decided to try this new method in the treatment of children with Vitiligo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33340 0
Address 33340 0
Country 33340 0
Phone 33340 0
Fax 33340 0
Email 33340 0
Contact person for public queries
Name 16587 0
Sadegh Hasheminasab
Address 16587 0
Dermatology wards, Afzalipour Hospital,Emam Khomeini High way, Kerman, Kerman province,Iran
postal code:7616913888
Country 16587 0
Iran, Islamic Republic Of
Phone 16587 0
+98 9111566484
Fax 16587 0
+98 341 3222270
Email 16587 0
hasheminasab.sadegh@gmail.com
Contact person for scientific queries
Name 7515 0
Saeedeh Farajzadeh
Address 7515 0
Dermatology wards, Afzalipour Hospital,Emam Khomeini High way, Kerman, Kerman province,Iran
postal code: 7616913888
Country 7515 0
Iran, Islamic Republic Of
Phone 7515 0
+98 9133414259
Fax 7515 0
+98 341 3222270
Email 7515 0
s_farajzadeh@kmu.ac.ir

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary