Protocol summary
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Study aim
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Evaluation of the effect of oral antihistamines in the treatment of alopecia areata patients and its comparison with conventional therapies.
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Design
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A randomized clinical trial with 48 patients in 3 groups of intervention
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Settings and conduct
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This study will be performed in dermatology clinics of Isfahan University of Medical Sciences. Patients with alopecia areata of the scalp or beard who are candidates for topical treatment are enrolled in the study.
At first, the plan is explained to the patient and Written consent is obtained.
Patinent's informations is recorded in special forms.The patients then randomly assigned to one of the three intervention groups.
At the beginning and 3 month after the last session, patients' lesions are photographed and evaluated and scored by two neutral dermatologists who are unaware of the type of intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: patients with alopecia areata, at least 12 years old, with a maximum of three areas of hair loss,
Exclusion criteria: Pregnant and lactating women, liver and kidney dysfunction, history of allergy to antihistamines and people with cold intolerance.
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Intervention groups
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Intervention group 1: Treatment with betamethasone 0.1% lotion. The patient uses one or two drops of the drug once a day (depending on the size of the bald area) for 12 weeks.
Intervention group 2: Treatment with betamethasone 0.1% lotion similar to the first group and cryotherapy with liquid nitrogen which is used by a cotton swab on the hair loss area for 8 to 10 seconds for a maximum of six sessions at intervals of two weeks.
Intervention group 3: Treatment with betamethasone 0.1% lotion and cryotherapy similar to the second group plus des loratadine 5 mg tablets daily for 12 weeks. The tablets are made by Abidi Company.
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Main outcome variables
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Percentage of terminal hair regrowth;Patient satisfaction
General information
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Reason for update
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Since during the implementation of the study, we realized that there are patients who benefit from this treatment because of their special clinical situation , but due to the limitation of the diameter of the lesions, they are not able to enter the study, and considering that in previous similar studies, the maximum diameter of the lesions has been reported up to 7 cm, it was decided to consider the maximum diameter of the lesions as 3 x 3 cm in the inclusion criteria.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210404050843N1
Registration date:
2021-05-14, 1400/02/24
Registration timing:
prospective
Last update:
2022-11-21, 1401/08/30
Update count:
1
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Registration date
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2021-05-14, 1400/02/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-05-22, 1400/03/01
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Expected recruitment end date
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2022-05-22, 1401/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effect of topical betamethasone, topical betamethasone with cryotherapy, topical betamethasone with cryotherapy and oral antihistamines on hair regrowth in alopecia areata patients
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Public title
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Effect of cryotherapy and oral antihistamine in treatment of Alopesia Areata
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
patient age above 12 years
Do not take another tratment for alopecia areata for at least one month before enrollment in this trial
Maximum of three hair loss patches in the scalp or beard area, each of which is a maximum of 3 by 3 cm.
No nail involvement related to alopecia areata
Exclusion criteria:
Renal or liver dysfunction
Patients with a history of allergy to antihistamines
Pregnancy or Lactation
Lack of patient cooperation to complete the treatment process
Cold intolerance
Cryoglobulinemia
History of cold urticaria
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Age
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From 12 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
48
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Three sets of 16 cards with the letters A, B and C written on them are prepared and placed in the bag, and each patient picks a card from the bag and their group is identified.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Factorial
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-03-20, 1399/12/30
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Ethics committee reference number
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IR.MUI.MED.REC.1399.1192
Health conditions studied
1
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Description of health condition studied
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Alopecia Areata
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ICD-10 code
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L63
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ICD-10 code description
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Alopecia areata
Primary outcomes
1
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Description
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Terminal hair regrowth percent
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Timepoint
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Before the intervention (at the beginning of the study )and three months after the last treatment session
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Method of measurement
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The evaluation is performed by the physician with the help of a questionnaire and based on the following scale:: Good response (more than 75% of terminal hair regrowth). Moderate response (between 50 and 75% of terminal hair regrowth). Poor response (between 25 to 50% of terminal hair regrowth) No response (less than 25% of terminal hair regrowth)
Secondary outcomes
1
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Description
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Patient satisfaction
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Timepoint
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Before the intervention (at the beginning of the study) and three months after the last treatment session
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Method of measurement
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Patient satisfaction rate by the questionnaire based on numerical selection from one to ten (0= no effect, 1,2= minor effect, 3,4= moderate effect, 5,6= good effect, 9,10= very good effect)
Intervention groups
1
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Description
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Intervention group1: Treatment with betamethasone lotion 0.1%(made by Iran Najo company) daily for 12 weeks.The patient applies one to two drops of the drug (depending on the size of the bald area) once daily. This is repeated every day for 12 weeks.
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: Treatment with betamethasone lotion 0.1%(made by Iran Najo company) daily for 12 weeks, similar to the first intervention group, and cryotherapy for a maximum of six sessions, every two weeks, for eight to ten seconds. Cryotherapy is done by liquid nitrogen available in dermatology clinic, with The cotton swab is held on the hair loss area for eight to ten seconds. Cryotherapy is repeated every two weeks until the desired result is achieved, but if no response is seen after six sessions, this treatment is discontinued.
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Category
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Treatment - Drugs
3
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Description
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Intervention group 3: Treatment with betamethasone lotion 0.1% (made by Iran Najo Company) daily for 12 weeks and cryotherapy for a maximum of six sessions every two weeks once each time eight to ten seconds similar to the second intervention group with des loratadine tablets 5 mg daily for 12 weeks. Des loratadine tablets made by Abidi Pharmaceutical Company. 90 units are prescribed for patients in this group.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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At the end of the study, study protocol, statistical analysis and clinical study report,the informed consent form, the codes used in the data analysis and the data dictionary can be shared with other researchers.
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When the data will become available and for how long
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Access period starts one month after the results are published
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To whom data/document is available
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Data will be available to researchers working in academic and scientific centers
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Under which criteria data/document could be used
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Researchers can use the findings and data of this study in their research by submitting a document that proves their employment in scientific and academic centers.
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From where data/document is obtainable
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Researchers can receive study data via sending an E-mail to researcher
E-mail:marziehmusavi@gmail.com
phone number: 09134610431
Dr Marzieh sadat Mousavi
address:No1, Adl St, Mirzataher Ave, Isfahan, Iran
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What processes are involved for a request to access data/document
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Researchers can send an email to the address to indicate the type of data they need, and after reviewing their request, the information will be sent to them via email.
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Comments
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