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CTRI Number  CTRI/2024/04/065363 [Registered on: 08/04/2024] Trial Registered Prospectively
Last Modified On: 21/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Other (Specify) [Fractional co2 laser]  
Study Design  Other 
Public Title of Study   Comparison of combination of fractional CO2 laser and daily topical steroid with intralesional steroid in alopecia areata 
Scientific Title of Study   Comparison of Combination of Fractional CO2 Laser and Daily Topical Steroid with Intralesional Steroid in Alopecia Areata- Open Randomised Therapeutic Trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tahura Fatima Ahmad 
Designation  Post Graduate student 
Affiliation  University college of medical sciences 
Address  Doctors duty room , dermatology department, Taharpur Rd, GTB Enclave, Dilshad Garden, New Delhi, Delhi, 110095

East
DELHI
110025
India 
Phone  7011990546  
Fax    
Email  tahura2307@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijay Gandhi 
Designation  Director Professor 
Affiliation  University College of medical sciences 
Address  Department of Dermatology, University College of medical sciences, Tahirpur Rd, GTB Enclave, Dilshad Garden, New Delhi, Delhi, 110095

East
DELHI
110095
India 
Phone  9810296835  
Fax    
Email  drvj125@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vijay Gandhi 
Designation  Director Professor 
Affiliation  University College of medical sciences 
Address  Department of Dermatology, University College of medical sciences, Tahirpur Rd, GTB Enclave, Dilshad Garden, New Delhi, Delhi, 110095


DELHI
110095
India 
Phone  9810296835  
Fax    
Email  drvj125@gmail.com  
 
Source of Monetary or Material Support  
University college of medical sciences, Taharpur Rd, GTB Enclave, Dilshad Garden, New Delhi, Delhi, 110095 
 
Primary Sponsor  
Name  Self Tahura Fatima Ahmad 
Address  L-11, ground floor , street no-9, zakir nagar, new delhi, 110025, India 
Type of Sponsor  Other [Self] 
 
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 Tahura Fatima Ahmad  Guru Teg Bahadur Hospital  Doctors duty room, department of dermatology,Tahirpur Rd, GTB Enclave, Dilshad Garden, New Delhi, Delhi, 110095
East
DELHI 
7011990546

tahura2307@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE – HUMAN RESEARCH (IEC-HR) UNIVERSITY COLLEGE OF MEDICAL SCIENCES, UNIVERSITY OF DELHI, DELHI - 110095  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  Fractional C02 laser and topical steroid Intralesional steroid  In group A lesion will be treated with ablative fractional CO2 laser followed by the daily local application of mometasone 0.01% cream. Patients will apply lidocaine anesthetic cream 1 h prior to the session. The area of AA will be cleaned with normal saline. Fractional CO2 laser (RF 50 Excited CO2 Laser- Dermaindia) will be used. The procedure will be carried out at a power-14W, fluence – 42mj/cm2 , dwell time – 3.0ms, distance – 1.1mm, MTZ- 100MTZ/cm2, repeat – single, passes- 2. After sessions patients will be instructed to apply a topical antibiotic(Fusidic acid cream) twice daily for 1 week and counselled for photoprotection. These parameters are selected to facilitate the transepidermal delivery of the topical steroid into the dermis. • In group B intralesional triamcinolone acetonide (5mg/ml) will be injected into deep dermis or upper subcutaneous tissue using a 0.5-inch-long 30-G needle at the sites, 1cm apart, and 0.1ml into each site.  
Comparator Agent  NIL  No comparator agent present in the study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  • Patients with patchy pattern of alopecia areata with two or more non-adjacent patches
• Above the age of 18 years.
• Not taken any form of treatment for at least 1 month.
 
 
ExclusionCriteria 
Details  1• Patients with confluent scalp lesions,
2• Patients with other patterns of alopecia areata (alopecia universalis, alopecia totalis, ophiasis)
3• Patients on anticoagulant
4• Pregnancy and lactation
• Patients with history of hypertrophic scar or keloid
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
assess hair regrowth after fractional co2 laser and topical application
assess hair regrowth after intralesional steroid in alopecia areata  
baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Compare the proportion of hair regrowth in both groups using macdonald hull and norris grading and trichoscopic grading scores used.
 
12- 13 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   17/04/2024 
Date of Study Completion (India) 26/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 is a chronic inflammatory disease which results in non-scarring hair loss. It occurs as an acute and complete loss of hair in a single or several areas  in the course of a few weeks. It can affect different areas such as scalp, beard, eyebrows, eyelashes or can be generalized being called alopecia universal 5.

Trichoscopy is used in patients with scarring or nonscarring alopecia conditions as a quick, noninvasive method to examine the scalp and hair. It is a helpful monitoring tool 6  Dermoscopic features of AA include:  Yellow dots: Round or polycyclic yellow to yellow‑pink dots that represent distended follicular infundibula filled with sebum and keratin remnants, black dots: remnant of broken hair shafts inside follicular ostia, exclamation mark hairs: broken hairs that tapered toward follicles, short vellus hairs: thin, nonpigmented hairs with length ≤10 mm may demonstrate early disease remission, broken hairs: due to fracture of dystrophic hair shafts or rapid regrowth of hairs that formerly manifested as black dots 7.

Trichoscopics features as indicators of activity8:

·       Black spots.

·        Exclamation mark hairs

·        Broken hair shafts

·        Pohl-Pinkus constriction

Trichoscopic findings seen in regrowth:

•        presence of thin and unpigmented vellus hair within the patch

•        evidence of transformation of vellus hair into terminal hair, appearing as increased proximal shaft thickness and pigmentation, characteristic of remitting disease and indicative of a response to treatment

•        decreased trichoscopic features such as yellow dots, black dots, broken hair, vellus hair and tapering or exclamation mark hair7.

The evaluation of the hair regrowth can be done using MacDonald Hull and Norris4 grading system which is as follows: Grade 0: no hair regrowth. Grade 1: regrowth of vellus hair. Grade 2: regrowth of sparse pigmented terminal hair. Grade 3: regrowth of terminal hair in clusters. Grade 4: complete regrowth of terminal hair over alopecia patch9.

Trichoscopic evaluation will be done using 2 grading scores:

  1. Dystrophic follicular units that is percentage of empty follicular units/dystrophic hair forms (yellow dots, black dots, broken hairs and exclamation mark hairs) in the representative fields of the patch area will be calculated as follows at baseline and 12 weeks:

•        0: no/empty follicular units or dystrophic hair in field

•         1: 1–24%

•        2: 25–49%

•        3: 50–74%

•        4: 75–100%)

  1. Terminal hair that is percentage of terminal hairs in the patch area will be calculated as follows at baseline and 12 weeks:

•        0: no terminal hair in field

•        1: 1–24%

•        2: 25–49%

•        3: 50–74%

•        4: 75–100%

 

 

Steroids with low solubility are preferred for their slow absorption from the injection site, promoting maximum local action with minimal systemic effect. Immunosuppression is the main mechanism of action. Corticosteroids suppress the T-cell-mediated immune attack on the hair follicle.10 Intralesional steroid are considered first line treatment in localized alopecia areata  involving ‹ 50% of scalp, although painful and associated with various side effects. Thus there is a need for alternative methods.

Laser treatments of different wave lengths have been used to manage alopecia areata including ablative Fractional laser11. The fractional laser produces a microthermal zone and creates numerous tiny columns of thermal injury12. Laser treatment can also precisely and selectively remove the stratum corneum in a controlled and noncontact manner, the laser also interacts with sebum to break up the barrier function, increasing the skin delivery of drugs13. The generation of microthermal zones by fractional lasers provides the channels for a uniform and controlled delivery of drugs. Fractional lasers can penetrate up to 2–3 mm into the dermis, depositing thermal energy where the dermal papilla is, which is where the capillaries surround the hair germ cells 14.

Lasers stimulate drug delivery by means of 3 processes; 1) tissue ablation, which removes the stratum corneum and the most superficial layers of the epidermis; 2) photomechanical waves, resulting from the conversion of light into mechanical energy giving the laser a therapeutic effect; and 3) non-ablative resurfacing where thermal and physical injuries disrupt the skin barrier, promoting the delivery of medications through these laser channels15

Fractional CO2 laser in combination with topical corticosteroid application shows excellent clinical response in resistant alopecia areata with negligible side effects.14

In a study comparing intralesional steroid versus fractional CO2 laser for alopecia areata, latter showed better response11

Fractionated Er: YAG laser with local corticosteroids has been proved to be efficient treatment modality in alopecia areata.16

In a study comparing fractional CO2 laser alone vs in combination with topical triamcinolone, with topical platelet rich plasma and with topical vitD3, all showed significant response.17

 It is highly recommended to only deliver drugs or molecules that are FDA-approved or studied for the dermis18. Ablative lasers are generally considered superior to non-ablative lasers. Non-ablative lasers disrupt the dermal epidermal junction but do not create an opening for larger molecules to gain access to the dermis18

LACUNAE

•        A similar study where fractional CO2 laser-assisted topical steroid delivery versus I/L steroid in the treatment of AA has been done in Egypt using topical triamcinolone acetonide involving 30 patients in 2021, where one patch was treated with fractional CO2 laser followed by a one time application of topical triamcinolone and other patch with I/L triamcinolone in which group 2 showed significantly higher improvement compared to group 1. However we have modified our study and suggested daily topical steroid application after fractional co2 laser therapy.

•        Similar studies have been done for other dermatosis such as hypertrophic scars, vitiligo etc

•        To the best of our knowledge, no studies have been conducted comparing the efficacy of  combination of fractional carbon dioxide laser and daily topical steroids with intralesional steroids in alopecia areata. The present study is an attempt to fill this gap in literature.

 
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