Comparison of Combination of Fractional CO2 Laser and Daily Topical Steroid with Intralesional Steroid in Alopecia Areata- Open Randomised Therapeutic Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- assess hair regrowth after fractional co2 laser and topical application
研究概览
简要总结
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 tool6 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 dots7.
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:
- 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%)
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •• 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.
排除标准
- •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.
结局指标
主要结局
assess hair regrowth after fractional co2 laser and topical application
时间窗: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks
assess hair regrowth after intralesional steroid in alopecia areata
时间窗: baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks
次要结局
- Compare the proportion of hair regrowth in both groups using macdonald hull and norris grading and trichoscopic grading scores used.
研究者
Tahura Fatima Ahmad
University college of medical sciences
