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IRCT20250308064975N1 IRCT 2025-05-20 Shaheed mohtarma benazir bhutto medical university larkana Effectiveness of intralesional triamcinolone acetonide plus tacrolimus or tacrolimus alone in young patient with alopecia areata. Comparison between intralesional triamcinolone acetonide plus tacrolimus and tacrolimus alone in young patient with alopecia areata 2024-12-24 anticipated 138 Complete https://irct.ir/trial/82396 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Community based ,parallel group ,non blinded randomized controlled trial, 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. N/A 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.. 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.. Yes - There is a plan to make this available What will be shared: 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: After 6 monyhs RCT ,for 4 years To whom: Primary investigator Conditions: All patients in dermatology OPD according to operational definition of alopecia areata fullfling the inclusion criteria. Where to obtain: Shaheed mohtarma Benazir Bhutto medical university larkana How to obtain: contact to primary investigator Comments:
public Dr Irfan shaikh
H52X+R45,Shah nawaz bhutto Rd
Larkana Pakistan 77150 +92 71 5614111 shaikhirfan913@gmail.com Shaheed mohtarma benazir bhutto medical university larkana scientific Dr Aftab shah
H52X+R45, shah nawaz bhutto Rd larkana
Larkana Pakistan 77150 +92 74 4752760 directororic@smbbmu.edu.pk Shaheed mohtarma benazir bhutto medical university larkana Pakistan Patient age between 12-50 years of both genders. Patient diagnosed with alopecia areata. 12 years 50 years Both Patient having SALT score < 50 at baseline Patient with autoimmune diseases Pregnant women Patient's on immunosuppression therapy. Non-consenting patient L63 Alopecia areata Treatment - Drugs 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. 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 . 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. Shaheed mohtarma benazir bhutto medical university larkana Approved 2025-05-06 Research and ethical review shaheed mohtarma benazir bhutto medical university larkana H52X+R45, shah nawaz bhutto rd ,larkana , Larkana Sindh Pakistan