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 Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 4.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Alopecia areata denovo cases
- •Treatment free period of at least 4 weeks prior joining to the study.
Exclusion Criteria
- •Patients with alopecia totalis, alopecia universalis, cicatricial alopecia and other causes of alopecia other than AA.
- •Patients with hematological disorders and patients on antiplatelet drugs
- •Pregnant and lactating females
- •Patients with active infections
- •Patients with keloidal tendency.
Outcomes
Primary Outcomes
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.
Time Frame: 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 Outcomes
- 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.)
Investigators
Dr. Eddula Venkata Ravikanth
Apollo Institute of Medical Sciences and Research Chittoor