Assessing efficacy of minoxidil 5% versus minoxidil 5%+topical spironolactone 2%
Design
Two arm parallel group randomized trial with blinded outcome assessment phase 2 on 60patients. Block randomization would be used for sampling.
Settings and conduct
Androgenic alopecia patients referred to Razi Hospital in 1401-1402 who are approved based on the inclusion and non-inclusion criteria would be included in this clinical trial. After obtaining written consent from the patient and recording the history, clinical information would be collected in pre-prepared questionnaires. Two groups and each group include 30 patients will be selected. Patients should avoid using other drugs to cure alopecia during the study period. All solutions are kept in a similar bottle where the usage and storage conditions of the medicine are written. The name of the medicine is not written on the bottle. All patients should apply the solution twice a day (morning and night). This procedure continues for 6 months. The patient will visit the medical center for 3 sessions (0-8-16weeks).
Participants/Inclusion and exclusion criteria
Inclusion: Aged 18-60
diagnosis of androgenic alopecia
not received any drug for alopecia in the past 12 months
Non-inclusion:
Pregnancy or breastfeeding
history of internal diseases
alteration in diet and lifestyle
polycystic ovary syndrome
The disease caused by another reason than androgenic alopecia
Consuming any systemic or topical drugs caused hair loss or regrowth
history of hair transplantation
History of skin diseases which cause hair loss like cutaneous cancers, infection, psoriasis
photosensitivity
Efficacy and safety of minoxidil 5% with or without spironolactone 2% in treating patients with androgenic alopecia
Public title
Effect of spironolactone and minoxidil solution in treatment of androgenic alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18-60
Clinical diagnosis of androgenic alopecia with a dermatologist
Have not received any drug for alopecia in the past 12 months
Exclusion criteria:
Pregnancy or breastfeeding during the intervention
history of internal diseases, including endocrine diseases causing alopecia
alteration in diet and lifestyle during the study
polycystic ovary syndrome
The disease caused by another reason than androgenic alopecia
Consuming any systemic or topical drugs which caused hair loss or hair regrowth
Have a history of hair transplantation
History of skin diseases which cause hair loss like cutaneous cancers, infection, psoriasis
photosensitivity
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Individual blocks will be created without stratified randomization by statistical software (Website of SealedEnvelope TM). And another person (rather than the doctor-researcher-patient) would do the randomization. For this, blocks of size 6 were selected for 2 treatment groups so that the total sample size would be 60. Based on this, a randomized sequence will be provided according to which the study subjects will receive the treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
The container containing the medicines will be without a drug name label and all the containers will be similar and indistinguishable. Another person out of the study will distribute the desired medicine to the patients based on the randomization sequence. Therefore, the physician, the outcome assessor, and the analyzer will remain unaware of the drug's content. According to the mentioned points, this study will be double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Vahdate eslami St. - Razi alley. Razi Dermatology Hospital
City
Tehran
Province
Tehran
Postal code
119963911
Approval date
2022-10-01, 1401/07/09
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.509
Health conditions studied
1
Description of health condition studied
Androgenic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia
Primary outcomes
1
Description
Hair regrrowth score
Timepoint
At the beginning of the study (before the start of the intervention) and 6 months after the start of trial
Method of measurement
Hair regrowth score based on the observations of two dermatologists assessing the before and after photographs
Secondary outcomes
1
Description
Patients' satisfaction with androgenic alopecia recovery
Timepoint
At the beginning of the study (before the start of the intervention) and 6 months after the start of trial
Method of measurement
Visual Analogue Scale
2
Description
Hair regrowth score based on Fotofinder device
Timepoint
At the beginning of the study (before the start of the intervention) and 6 months after the start of trial
Method of measurement
Hair density (hairs/cm2) and Hair diameter (hairs/cm2)
Intervention groups
1
Description
Intervention group 1: minoxidil 5% solution/ The solution would be applied on the head twice a day (morning and night) for 6 months. This solution will be manufactured by the pharmacy of Razi Hospital.
Category
Treatment - Drugs
2
Description
Intervention group 2: spironolactone 2% solution plus minoxidil 5%/ The solution would be applied on the head twice a day (morning and night) for 6 months. This solution will be manufactured by the pharmacy of Razi Hospital.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Zeinab Aryanian
Street address
Vahdate eslami St. Razi alley. Razi Dermatology Hospital
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Email
z_aryanian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Hamzelou
Street address
Vahdate eslami St. Razi alley. Razi Dermatology Hospital
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 6663 0553
Email
dr.hamzelou@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nika Kianfar
Position
Post doctorate fellow
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No.1, afshar alley, daavi alley, pasdaran ave.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Fax
Email
nika_kianfar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nika Kianfar
Position
Post doctoral fellow
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No.1, afshar alley, daavi alley, pasdaran ave.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0553
Fax
Email
nika_kianfar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nika Kianfar
Position
Post doctoral fellow
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
No.1, afshar alley, daavi alley, pasdaran ave.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0511
Fax
Email
nika_kianfar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data file information of the participants - study protocol - statistical analysis plan - informed consent form will be published after de-identification.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Receiving data will be available for researchers working in academic and scientific institutions or people who are also engaged in industry
Under which criteria data/document could be used
In order to conduct scientific studies
From where data/document is obtainable
Dr. Nika Kianfar nika_kianfar@yahoo.com
What processes are involved for a request to access data/document
After sending the request by providing a logical reason, the data will be sent to the person within 2 weeks.