Evaluation of Latanoprost Combined With Fractional Erbium- YAG Laser

NCT ID: NCT06239324

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-05-01

Brief Summary

Alopecia areata (AA) an autoimmune disorder of hair follicles results in varying degrees of scalp, facial and body hair loss.

Clinically, patients' presentation varies from patchy circumscribed scalp involvement to total body and scalp hair loss affects up to 2% of the general population.

The exact pathobiology of AA has still remained elusive, while the common theory is the collapse of the immune privilege of the hair follicle caused by immunological mechanism. Multiple genetic, environment factors and psychological stress contribute to the pathogenesis of Alopecia Areata .

Recent insights into the pathogenesis of AA have led to the development of new treatment strategies, such as Janus kinase inhibitors, biologics and several small molecular agents. In addition, modern therapies for AA, including antihistamines, platelet-rich plasma injection

Detailed Description

Latanoprost is a prostaglandin analogue with well-established efficacy in the treatment of open-angle glaucoma and ocular hypertension.

Make an increase in the number, thickness and length of eyelashes is an important side effect of latanoprost eye drop. This study aimed to evaluate the effect of hypertrichosis property of latanoprost in the treatment of scalp Alopecia Areata.

Numerous techniques and agents such as microneedling, dermabrasion, radiofrequency and lasers have been used to increase penetration within an approach known as transdermal drug delivery.

One of these techniques is laser-assisted drug delivery (LADD), which often uses ablative fractional lasers (CO2 or erbium: YAG lasers) because of their capacity to produce microscopic ablated channels.

LADD is a promising technique that enhances the absorption of topical molecules while adding the synergic effect.

Microneedling is a form of therapy that utilizes instruments that contain rows of thin needles that penetrate the dermis to uniform depth, creating a controlled skin injury.

Transcutaneous drug delivery via fractional laser and microneedling is a promising modality with preliminary evidence for increased hair regrowth over topical therapy alone.

Trichoscopy is a noninvasive procedure performed in dermatology clinics and is a helpful tool in determining the correct diagnosis of hair loss presentations. The five most characteristic trichoscopic findings in AA are yellow dots, black dots, broken hairs, short vellus hairs and tapering hairs. Also trichoscopy is a useful tool that allows monitoring of response during treatment of AA.

Conditions

Alopecia Areata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fractional Erbium laser Technique (Group A)

About 35 patients with alopecia areata will Subject to fractional Erbium (Er-YAG) laser (Fotona Xs dynamics,Slovenia) with energy of 600 mj in short pulse mode (MSP) with spot size of 7 mm diameter, frequency of 3 Hz and pixel 3. Latanoprost( xalatan 0.005% ) is applied to the treated area for all participants.

Group Type: ACTIVE_COMPARATOR

Latanoprost

Intervention Type: DRUG

Comparing between Erbium YAG laser assisted drug delivery of latanoprost versus transepidermal latanoprost delivery by microneedling in alopecia areata treatment for all participants.

Micro needling Technique (Group B)

About 35 patients with alopecia areata will Subject to micro needling using electronic dermapen device (Dr Pen Derma PenUltima A6) which has a disposable head personalized for each patient and sterilized after each session. the dermapen will penetrate the skin with depth 0.6 mm. It will pass vertically over the affected area in a circular pattern until pinpoint bleeding appears. Latanoprost ( xalatan 0.005% ) is applied to the treated area for all participants.

Group Type: ACTIVE_COMPARATOR

Latanoprost

Intervention Type: DRUG

Comparing between Erbium YAG laser assisted drug delivery of latanoprost versus transepidermal latanoprost delivery by microneedling in alopecia areata treatment for all participants.

Interventions

Latanoprost

Comparing between Erbium YAG laser assisted drug delivery of latanoprost versus transepidermal latanoprost delivery by microneedling in alopecia areata treatment for all participants.

Intervention Type: DRUG

Other Intervention Names

fractional Erbium- YAG laser

Eligibility Criteria

Inclusion Criteria

• Patients of both sexes with localized stable alopecia areata of the scalp of 3 months duration at least.

Exclusion Criteria

1. Acute or chronic infections.

2. Pregnant or lactating women.

3. Scarring alopecia.

4. Alopecia totalis , Alopecia universalis and ophiasis.

5. Autoimmune dermatological diseases.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Egymedicalpedia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soheir AbdelHamid Ali, Assist. Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of dermatology , Venerolgy and Andrology Faculty of Medicine Qena university

Locations

Qena Hospital

Qina, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Maha Nabil Fahmy, Resident

Role: CONTACT

mahanabilsoady@gmail.com

01012004848

Hassan Ibrahim, Assist.prof

Role: CONTACT

hassan.mohamed@med.svu.edu.eg

01011524245

Facility Contacts

Eisa Hegazy, Assist.Prof

Role: primary

eisa_mohamed4152@med.svu.edu.eg

01094337795

Other Identifiers

Maha Nabil

Identifier Type: -

Identifier Source: org_study_id