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CTRI Number  CTRI/2024/03/064833 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 21/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study done to find out how well triamcinolone acetonide, pentoxifylline, and the two of them together help in growing hair back after being injected into areas where alopecia areata has caused hair loss. 
Scientific Title of Study   A clinico- dermoscopic study of comparison of intralesional triamcinolone acetonide, pentoxifylline and their combination in treatment of alopecia areata 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prathibha J P 
Designation  Assistant Professor 
Affiliation  St. Johns Medical College Hospital 
Address  Department of Dermatology, St. Johns Medical College Hospital, Sarjapur Road, Bangalore - 560034, Karnataka, India.

Bangalore
KARNATAKA
560034
India 
Phone  9886695980  
Fax    
Email  prathibha.jp@stjohns.in  
 
Details of Contact Person
Scientific Query
 
Name  Vinayak Viswanath 
Designation  Senior Resident 
Affiliation  St. Johns Medical College Hospital 
Address  Department of Dermatology, St. Johns Medical College Hospital, Sarjapur Road, Bangalore - 560034, Karnataka, India.

Bangalore
KARNATAKA
560034
India 
Phone  9400726787  
Fax    
Email  vinayak.viswanath@StJohns.in  
 
Details of Contact Person
Public Query
 
Name  Vinayak Viswanath 
Designation  Senior Resident 
Affiliation  St. Johns Medical College Hospital 
Address  Department of Dermatology, St. Johns Medical College Hospital, Sarjapur Road, Bangalore - 560034, Karnataka, India.

Bangalore
KARNATAKA
560034
India 
Phone  9400726787  
Fax    
Email  vinayak.viswanath@StJohns.in  
 
Source of Monetary or Material Support  
St. Johns Medical College Hospital, Sarjapur Road, Bangalore - 560034, Karnataka, India. 
 
Primary Sponsor  
Name  Vinayak Viswanath 
Address  Senior Resident, Department of Dermatology, St. Johns Medical College Hospital, Sarjapur Road, Bangalore - 560034, Karnataka, India. 
Type of Sponsor  Other [Principal Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vinayak Viswanath  St. John’s Medical College Hospital  Dermatology Procedure Room, Dermatology Outpatient Department, Department of Dermatology, St. John’s Medical College Hospital, Sarjapur Road, Bangalore- 560 034, India
Bangalore
KARNATAKA 
9400726787

vinayak.viswanath@StJohns.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St. John’s National Academy of Health Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L639||Alopecia areata, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intralesional injection of combination of triamcinolone acetonide and pentoxifylline  0.1 ml of combination of two part triamcinolone acetonide (10 mg per mL) and one part of pentoxifylline (20 mg per mL) (the combined concentration was 5 mg triamcinolone acetonide and 5 mg pentoxifylline) injected intralesionally into patch using a insulin syringe (0.5 inch long syringe with 30 gauge needle) every month. Injections are given at 1 cm intervals with a maximum of 1 mL of drug per visit. 
Intervention  Intralesional injection of pentoxifylline  0.1 mL pentoxifylline (20 mg per mL concentration) injected intralesionally into patch using a insulin syringe (0.5 inch long syringe with 30 gauge needle) every month till lesion resolves. Injections are given at 1 cm intervals with a maximum of 1 mL of drug per visit. 
Comparator Agent  Intralesional injection of triamcinolone acetonide  0.1 mL Triamcinolone acetonide (10 mg per mL concentration) injected intralesionally into patch using a insulin syringe (0.5 inch long syringe with 30 gauge needle) every month till lesion resolves. Injections are given at 1 cm intervals with a maximum of 1 mL of drug per visit. 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Clinically and dermoscopically diagnosed patients with single or multiple patches of alopecia areata 
 
ExclusionCriteria 
Details  1. Non-consenting patients
2. Patients with alopecia affecting more than 50% of scalp
3. Any treatment taken for alopecia in the past one month.
4. Prior history of allergic reactions to pentoxifylline, triamcinolone, or injection adjuvants or components
5. Pregnant and lactating females
6. Localised infection at injection site.
7. Known case of HIV, Hepatitis B and Hepatitis C or any other immune-compromised disease
8. Patient on systemic steroids or any other immunosuppressive treatment.
9. Acute febrile or any other bacterial infection.
10. Asthma, allergic skin disorder, history of convulsions
11. Bleeding disorders.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Hair regrowth in alopecia patches measured using 5-point semi-quantitative score regrowth scale (RGS) and dermoscopically.  Monthly assessment till 6 months after last injection 
 
Secondary Outcome  
Outcome  TimePoints 
Dermoscopic changes of alopecia areata during treatment  Monthly assessment till 6 months after last injection 
 
Target Sample Size   Total Sample Size="93"
Sample Size from India="93" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   08/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Alopecia areata (AA) is a common autoimmune disease that targets hair follicles with a prevalence of approximately 0.1% and a lifetime incidence of approximately 1.7%, which presents as patchy, non-scarring hair loss. 1

Pentoxifylline (PTX) is a methylxanthine derivative that acts as a phosphodiesterase inhibitor, raises the levels of cAMP in smooth muscle of the veins, and is known for its

vasodilator activity, and it is primarily used in microcirculatory disorders. PTX is sometimes regarded as a rheological agent because of its action on red blood cells. It enhances the resilience of erythrocytes and, besides, boosts blood supply in the arteries.

PTX has been used in dermatological disorders mostly as an adjunctive therapy with beneficial effects as it improves blood circulation and oxygen supply.3

The most common uses are peripheral vascular disease ,  vasculopathies and vasculitides, venous leg diseases and ulcers,  pigmented purpuric dermatoses, aphthosis and behcet’s disease, leprosy, AIDS , leishmaniasis, psoriasis, graft versus host disease, sarcoidosis, peyronie’s disease, radiation induced fibrosis and burns, keloids, scleroderma, morphea, oral submucous fibrosis, pseudoxanthoma elasticum, actinic prurigo, irritant and allergic hypersensitivity reactions, lipodermatosclerosis, ulcerating necrobiosis lipoidica, SJS and TEN. 4

The synthesis of TNF-α, a large pro-inflammatory mediator with wide-spectrum activity and released mainly by mononuclear cells, is believed to be inhibited by PTX.

PTX pharmacological activity may have significant ramifications in medical disease processes where local and systemic regulation of TNF may be needed to regulate particular immune processes. 5

PTX, in addition to inhibiting the synthesis of TNF-α, appears to increase the divergence of the cell secretions more toward the manufacturing of TH 2 cytokines, suppressing, on the other hand, cytokines of the TH 1 subset, like IFN-γ.6

A systematic review and network meta-analysis, which included 54 RCTs consisting of 49 treatment options and 3149 patients, suggested that oral pentoxifylline plus topical corticosteroids had the highest treatment success rate compared to “no treatment,” although the superiority to many other treatments is uncertain. 7

Intralesional therapy has a number of advantages over topical therapy, including a faster and longer duration of action, penetration that is deeper than topical therapy, the removal of the need for long-term topical medication, and improved patient compliance. The effect of microneedling for the treatment of AA is supposed to stimulate the dermal papilla and stem cells by mechanical trauma and increase the blood supply to the hair follicles.

A previous study showed the intralesional injection of a combination of pentoxifylline and triamcinolone to be significantly superior to pentoxifylline alone, followed by triamcinolone alone, in the treatment of alopecia areata. 8

However, dermoscopic changes during treatment of alopecia and clinical resolution with pentoxifylline have not been studied. Hence, we aim to study the efficacy of pentoxifylline and the dermoscopic changes compared to triamcinolone in the treatment of alopecia areata.

References :

1.         Biran R, Zlotogorski A, Ramot Y. The genetics of alopecia areata: new approaches, new findings, new treatments. J Dermatol Sci. 2015 Apr;78(1):11–20.

2.         Ahmadi M, Khalili H. Potential benefits of pentoxifylline on wound healing. Expert Rev Clin Pharmacol. 2016;9(1):129–42.

3.         Çakmak SK, Çakmak A, Gönül M, Kiliç A, Gül Ü. Pentoxifylline use in dermatology. Inflamm Allergy Drug Targets. 2012 Dec;11(6):422–32.

4.                  Hassan I, Dorjay K, Anwar P. Pentoxifylline and its applications in dermatology. Indian Dermatol Online J. 2014 Oct;5(4):510-6.

5.         Strieter RM, Remick DG, Ward PA, Spengler RN, Lynch JP, Larrick J, et al. Cellular and molecular regulation of tumor necrosis factor-alpha production by pentoxifylline. Biochem Biophys Res Commun. 1988 Sep 30;155(3):1230–6.

6.         de Sá Oliveira T, Capp Neto M, Martins BJ, Rodrigues HA, Antonino RM, Magalhães AV. Action of pentoxifylline on experimental cutaneous leishmaniasis due to Leishmania (Leishmania) amazonensis. Mem Inst Oswaldo Cruz. 2000;95(4):477–82.

7.         Fukumoto T, Fukumoto R, Magno E, Oka M, Nishigori C, Horita N. Treatments for alopecia areata: A systematic review and network meta-analysis. Dermatologic Therapy. 2021;34(3):e14916.

8.         El‐Taweel A‐AI, Akl EM. Intralesional pentoxifylline injection in localized alopecia areata. J Cosmet Dermatol. 2019;18:602–60

 
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