Evaluation of Latanoprost Combined With Fractional Erbium- YAG Laser

April 12, 2024 updated by: Egymedicalpedia

Evaluation of Latanoprost Combined With Fractional Erbium- YAG Laser Versus Microneedling in Alopecia Areata Treatment

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Latanoprost
Comparing between Erbium YAG laser assisted drug delivery of latanoprost versus transepidermal latanoprost delivery by microneedling in alopecia areata treatment for all participants.
Other Names:
  • fractional Erbium- YAG laser
Active Comparator: 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.
Drug: Latanoprost
Comparing between Erbium YAG laser assisted drug delivery of latanoprost versus transepidermal latanoprost delivery by microneedling in alopecia areata treatment for all participants.
Other Names:
  • fractional Erbium- YAG laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fractional Erbium YAG laser
Time Frame: from baseline to 3 months after the fractional Erbium YAG laser treatment day.
The Number of Participants With Treatment of fractional Erbium YAG laser assisted delivery of latanoprost versus micro needling with trans-epidermal latanoprost delivery to induce hair growth in alopecia areata.
from baseline to 3 months after the fractional Erbium YAG laser treatment day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Egymedicalpedia

Investigators

  • Principal Investigator: Soheir AbdelHamid Ali, Assist. Prof., Department of dermatology , Venerolgy and Andrology Faculty of Medicine Qena university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

April 20, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Actual)

February 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Maha Nabil

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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