| CTRI Number |
CTRI/2024/07/070279 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Fractional Co2 laser Machine] |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Laser and Ointment Treatments to Traditional Injections for Alopecia Areata A Study on Effectiveness and Safety |
|
Scientific Title of Study
|
Comparative Study of Fractional CO2 Laser with Topical Tacrolimus 0.1 percent and Tofacitinib 2 percent Ointments versus Intralesional Triamcinolone Acetonide in Alopecia Areata a Clinical and Trichoscopic Evaluation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Eddula Venkata Ravikanth |
| Designation |
Assistant Professor |
| Affiliation |
Apollo Institute of Medical Sciences and Research Chittoor |
| Address |
Room no. 12, Department of DVL, out patient department block, District Headquarter Hospital,
Apollo Institute of Medical Sciences and Research Chittoor, near murukambattu,
Chittoor
ANDHRA PRADESH
517127
India |
| Phone |
9966789376 |
| Fax |
|
| Email |
ravikanthmikado@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Eddula Venkata Ravikanth |
| Designation |
Assistant Professor |
| Affiliation |
Apollo Institute of Medical Sciences and Research Chittoor |
| Address |
Room no. 12, Department of DVL, Out patient department block, District Headquarter Hospital,
Apollo Institute of Medical Sciences and Research Chittoor, near murukambattu,
Chittoor
ANDHRA PRADESH
517127
India |
| Phone |
9966789376 |
| Fax |
|
| Email |
ravikanthmikado@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Eddula Venkata Ravikanth |
| Designation |
Assistant Professor |
| Affiliation |
Apollo Institute of Medical Sciences and Research Chittoor |
| Address |
Room no. 12, Department of DVL, out patient department block, District Headquarter Hospital,
Apollo Institute of Medical Sciences and Research Chittoor, near murukambattu,
Chittoor
ANDHRA PRADESH
517127
India |
| Phone |
9966789376 |
| Fax |
|
| Email |
ravikanthmikado@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Institute of Medical Sciences and Research Chittoor, near murukambattu, chittoor, Andhra Pradesh, India - 517127 |
|
|
Primary Sponsor
|
| Name |
Apollo Institute of Medical Sciences and Research Chittoor |
| Address |
Apollo Institute of Medical Sciences and Research Chittoor, Near Murukambattu, chittoor, Andhra Pradesh , India - 517127 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Eddula Venkata Ravikanth |
Apollo Institute of Medical Sciences and Research Chittoor |
Room no. 12,Department of DVL, Out patient department block,
Chittoor
ANDHRA PRADESH |
9966789376
ravikanthmikado@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIMSR, Chittoor |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L638||Other alopecia areata, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fractional Co2 laser |
The laser treatment will be administered every 4 weeks for a total of 6 sessions, and topical tacrolimus 0.1% ointment will be applied twice daily for the duration of the 6 sessions. |
| Intervention |
Fractional Co2 laser |
The laser treatment will be administered every 4 weeks for a total of 6 sessions, and topical tofacitinib 2% ointment will be applied twice daily for the duration of the 6 sessions. |
| Comparator Agent |
Triamcinolone acetonide 10mg/ml |
Intralesional Triamcinolone acetonide 10mg/ml will be injected at the patches of hair loss area every 4 weeks once up to 6 sessions |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Alopecia areata denovo cases
2. Treatment free period of at least 4 weeks prior joining to the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients with alopecia totalis, alopecia universalis, cicatricial alopecia and other causes of alopecia other than AA.
2. Patients with hematological disorders and patients on antiplatelet drugs
3. Pregnant and lactating females
4. Patients with active infections
5. Patients with keloidal tendency.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Comparison of efficacy in treating alopecia areata between Fractional CO2 laser combined with topical 0.1% ointment, topical tofacitinib 2% ointment, and traditional intralesional triamcinolone acetonide injections. |
All three treatment modalities will be administered every 4 weeks for a total of 6 sessions, spanning up to 24 weeks. The efficacy comparison will be conducted at the end of 40 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Trichoscopic evaluation of therapeutic response to the three treatment modalities.
2. Monitoring & evaluation of the safety & tolerability of each treatment approach, including documentation of any adverse effects or complications.
|
Trichoscopic evaluations will be conducted at baseline & then every 8 weeks (i.e., at baseline, week 8, week 16, week 32, & week 40) up to 40 weeks.
Safety, tolerability, & side effects will be recorded at each session, accompanied by serial photographs. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 4 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Introduction/background of the study: Alopecia areata
(AA) is a common autoimmune disorder characterized by non-scarring hair loss,
which can significantly impact patients’ quality of life and psychological
well-being. The pathogenesis of AA involves a complex interplay between genetic
predisposition, environmental factors, and immune system dysregulation, leading
to the targeted destruction of hair follicles.
Traditional
treatments for AA, such as intralesional corticosteroids, have shown varying
degrees of success but are often associated with side effects and limitations
in efficacy. In recent years, novel therapeutic approaches have been explored
to enhance treatment outcomes and minimize adverse effects. Among these,
fractional CO2 laser therapy has emerged as a promising modality due to its
ability to stimulate hair regrowth through the induction of localized
micro-injury and subsequent healing processes.
Combining
fractional CO2 laser therapy with topical immunomodulatory agents offers a
potential synergistic effect. Tacrolimus 0.1% ointment, a calcineurin
inhibitor, and tofacitinib 2% ointment, a Janus kinase (JAK) inhibitor, have
shown efficacy in managing various dermatological conditions by modulating
immune responses. However, their combined use with fractional CO2 laser in
treating AA has not been extensively studied.
This
study aims to conduct a comparative evaluation of the efficacy of fractional
CO2 laser therapy combined with topical tacrolimus 0.1% ointment, topical
tofacitinib 2% ointment, and intralesional triamcinolone acetonide in the
treatment of alopecia areata. By assessing clinical outcomes and utilizing
trichoscopic analysis, we seek to determine the most effective treatment
combination, providing insights into optimizing therapeutic strategies for
patients suffering from this challenging condition. Objectives:
1.
To compare the efficacy
of Fractional CO2 laser combined with topical 0.1% ointment and topical tofacitinib 2% ointment to
traditional Intralesional triamcinolone acetonide injections in treatment of
alopecia areata.
2.
Trichoscopic evaluation
of therapeutic response to the three modalities of treatment
3.
To monitor and evaluate
the safety and tolerability of each treatment approach, documenting any adverse
effects or complications
|