The objective is to evaluate the effectiveness of combined treatment with triamcinolone acetonide and I/L plus tacrolimus versus tacrolimus alone in young patients with AA ,the study aims to compare clinical outcomes ,including symptoms resolution,improvement in hair fall & patient satisfaction between the two treatment regimens.
Design
Community-based ,parallel group .non blind ,randomized controlled trial.
Settings and conduct
This study will be conducted on patients presenting in dermatology OPD fulfilling the inclusion criteria and study is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria for the study are diagnosed cases of alopecia areata,patient age between 12-50 years of either sex,those willing to provide informed consent.
Patient diagnosed with alopecia areata.
Exclusion Criteria include ,patient having SALT score < 50 at baseline.
Non-consenting patient.
Patient with autoimmune diseases.
Pregnant women.
Patient's on immunosuppression therapy.
Intervention groups
All patient will be randomly divided into 2 groups by using sequentially numbered opaque envelop. Patient in group A will receive intralesional triamcinolone Acetonide with topical tacrolimus 0.1% while group B will receive topical tacrolimus 0.1%. In group A, intralesional triamcinolone Acetonide 10mg will be given every 3 weeks along with topical tacrolimus 0.1% twice a day for 12 weeks. In group B, topical tacrolimus 0.1% will be advise twice a day for 12 weeks.
Main outcome variables
Final outcome efficacy will be evaluated after 12 weeks of treatment by using SALT score as per criteria mentioned in operational definition. All the findings confounding variables such as age, gender, residence and duration of hair loss will be noted in a predesigned performa.Efficacy in intralesional triamcinolone Acetonide with tacrolimus groups was higher as compared to tacrolimus alone (53.33% vs 30%).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250308064975N1
Registration date:2025-05-20, 1404/02/30
Registration timing:registered_while_recruiting
Last update:2025-05-20, 1404/02/30
Update count:0
Registration date
2025-05-20, 1404/02/30
Registrant information
Name
Irfan Shaikh
Name of organization / entity
Shaheed mohtarma benazir bhutto medicaL university larkana
Country
Pakistan
Phone
+92 71 5614111
Email address
shaikhirfan913@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-24, 1403/10/04
Expected recruitment end date
2025-06-24, 1404/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between intralesional triamcinolone acetonide plus tacrolimus and tacrolimus alone in young patient with alopecia areata
Public title
Effectiveness of intralesional triamcinolone acetonide plus tacrolimus or tacrolimus alone in young patient with alopecia areata.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient age between 12-50 years of both genders.
Patient diagnosed with alopecia areata.
Exclusion criteria:
Patient having SALT score < 50 at baseline
Patient with autoimmune diseases
Pregnant women
Patient's on immunosuppression therapy.
Non-consenting patient
Age
From 12 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
138
More than 1 sample in each individual
Number of samples in each individual:
69
69 in each group of either sex
Randomization (investigator's opinion)
Randomized
Randomization description
All patient will be randomly divided into 2 groups by using sequentially numbered opaque envelop. Patient in group A will receive intralesional triamcinolone Acetonide with topical tacrolimus 0.1% while group B will receive topical tacrolimus 0.1%. In group A, intralesional triamcinolone.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Community based ,parallel group ,non blinded randomized controlled trial.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and ethical review shaheed mohtarma benazir bhutto medical university larkana
Street address
H52X+R45, shah nawaz bhutto rd ,larkana ,
City
Larkana
Postal code
77150
Approval date
2025-05-06, 1404/02/16
Ethics committee reference number
NO.SMBBMU/IRB/25
Health conditions studied
1
Description of health condition studied
Alopecia areata (AA) is an autoimmune disorder. Patient presenting with hairless baldness together with healthy skin and conserved follicular ostia. Hairs with exclamations mark and a test of positive pull are done to confrm diagnosis . Yellow spots can been seen on dermoscopy. Spared white hairs; a pigment less regrowth. Disease diagnosis will be confirmed on histopathology which shows an infiltrated inflammation of small lymphocytes which surrounds the follicular bulb in anagen. involves the nonscarring permanent reduction of the hair leading to loss of hair from the scalp. AA can occur as a result of self limiting disease with multiple patchy hair loss , as a chronic illness with many patches reoccur & remitt over many years, or whole scalp hair loss or universal loss of terminal hair.
ICD-10 code
L63
ICD-10 code description
Alopecia areata
Primary outcomes
1
Description
primary outcome in patients with alopecia areata after treatment with intralesional (I/L) triamcinolone and tacrolimus in a randomized clinical trial typically involves assessing hair regrowth. Using trichoscan that analyzes hair density, thickness, and regrowth and taking standardized photographs of the affected area at baseline and follow-up visits to visually assess hair regrowth.Hair regrowth scoring as SALT (Severity of Alopecia Tool) score.
Timepoint
Patient is assessed ,before intervention and at 3,6,9,12 weeks after intervension
Method of measurement
Score based on SALT can be calculated using the measurement of the total percentage of hairs that are lost in four areas of the scalp — In the rightside profile (it accounts for 18% of the total area in the scalp), the left side profile (which also accounts for 18% of the total area in the scalp), at the vertex areas (40% of the total area of the scalp), and the posterior (24% of the total area of the scalp), as shown in the figure below. By including total percentage of hairs that are lost in each area are multiplied by the regions relative area, one attains a composite score total i.e the Score of SALT. The regrowth of the hair can be achieved through decreasing the SALT score (e.g, The SALT score can be consider 0 if there is complete hair regrowth. There is a simple tool for the calculation of SALT score based on loss of hair in each of the above mentioned areas.Online SALT score is available to predict hair regrow with treatment .
Secondary outcomes
1
Description
Side effects. Monitoring & documenting adverse effects related to the treatment ,skin irritation,bleeding ,scaring,telangiectasia.
Timepoint
Patient will assessed at 3,6,9,12 weeks after intervension
Method of measurement
Patient self-report: patient will be asked to report any discomfort,such as skin irritation,dryness,or allergic reactions during follow up vists. Clinical observation:inspect the treated areas for signs of adverse reactions sach as redness ,swelling or peeling. Efficacy will be assesed using the same parameters as the intervension group: improvement in clinical signs, presence of initially soft hairs regrow followed by pigmented hairs
Intervention groups
1
Description
Intervention Groups Record 1:Group A (Intervention Group) Intervention:Intralesional Triamcinolone Acetonide 10mg every 3 weeks + Topical Tacrolimus 0.1% twice a day for 12 weeks. Record 2: Group B (Control Group) Intervention:Topical Tacrolimus 0.1% twice a day for 12 weeks. Study Details. Randomization: Sequentially numbered opaque envelopes . Follow-up: 3, 6, 9, and 12 weeks. Outcome Evaluation: SALT score after 12 weeks . Confounding Variables: Age, gender, residence, and duration of hair loss.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and ethical review commitee shaheed mohtarma benazir bhutto medical university larkana
Full name of responsible person
Dilshad parveen
Street address
Shaheed mohtarma benazir medical university near shahnawaz road larkana
City
Larkana
Postal code
77150
Phone
+92 300 0936993
Email
innocentfairy309@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shaheed mohtarma benazir bhutto medical university larkana
Full name of responsible person
Dr Dilshad parveen
Street address
H52X+R45,SHAH NAWAZ BHUTTO RD
City
Larkana
Postal code
77150
Phone
+92 300 0936993
Email
innocentfairy309@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shaheed mohtarma benazir bhutto medical university larkana
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Shaheed mohtarma benazir bhutto medical university larkana
Full name of responsible person
Dr Irfan shaikh
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
H52X+R45,Shah nawaz bhutto Rd
City
Larkana
Province
Sindh
Postal code
77150
Phone
+92 71 5614111
Email
shaikhirfan913@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shaheed mohtarma benazir bhutto medical university larkana
Full name of responsible person
Dr Aftab shah
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
H52X+R45, shah nawaz bhutto Rd larkana
City
Larkana
Province
Sindh
Postal code
77150
Phone
+92 74 4752760
Email
directororic@smbbmu.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Shaheed mohtarma benzir bhutto medical university larkana
Full name of responsible person
Dr Dilshad parveen
Position
Post graduate resident
Latest degree
Bachelor
Other areas of specialty/work
Dermatology
Street address
C529+WQC SMBB MEDICAL UNIVERSITY LARKANA
City
larkana
Province
sindh
Postal code
77150
Phone
+92 336 2337504
Email
innocentfairy309@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
COMPARISON BETWEEN INTRALESIONAL TRIAMCINOLONE ACETONIDE PLUS TACROLIMUS AND TACROLIMUS ALONE IN YOUNG PATIENT WITH ALOPECIA AREATA.
PERFORMA
S.No: ______________
MR No: ______________
Group: Triamcinolone Acetonide with topical tacrolimus Topical Tacrolimus
Age: ______________(Years)
Gender: Male Female
Residence: Urban Rural
Duration of hair loss: ______________ (Months)
Time Point Severity of Alopecia Tool (SALT) Score
Baseline
3rd Week
6th Week
9th Week
12th Week
When the data will become available and for how long
After 6 monyhs RCT ,for 4 years
To whom data/document is available
Primary investigator
Under which criteria data/document could be used
All patients in dermatology OPD according to operational definition of alopecia areata fullfling the inclusion criteria.
From where data/document is obtainable
Shaheed mohtarma Benazir Bhutto medical university larkana
What processes are involved for a request to access data/document