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NCT Number: NCT05600673

Combined CO2 Fractional Laser With Bimatoprost 0.03% Treatment of Alopecia Areata

The goal of this study is to evaluate the efficacy and safety of combined CO2 fractional laser with Bimatoprost 0.03% as novel treatment of alopecia areata.

The main question to study is will the bimatoprost facilitate hair growth if added to fractional CO2 laser treatment in Alopecia areata.

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Key information

Conditions

Alopecia Areata Alopecia Hair Diseases Hypotrichosis Skin Diseases Skin and Connective Tissue Diseases

Age range

16 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

AL-Azhar University Hospital

Cairo, 11865, Egypt

About this study

The study included 30 patients who were diagnosed clinically and dermoscopically as alopecia areata with age ranged between 16-55 years. The patients are divided into 2 groups: Group I, received fractional laser sessions with immediate and daily Bimatoprost application and Group II, received only frequent Laser sessions. Laser sessions were given to each patch once every 3 weeks, the procedure was repeated for 3 times.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with alopecia areata of the scalp (multilocuolaris or single patch).
  • Patient aged from 16- 55 years old in both sex.
  • Other treatment wash out period is two months.

Exclusion criteria

  • Ophiasis pattern and other patterns of alopecia areata.
  • Chronic diseases of liver, heart, kidney and blood
  • Pregnant women
  • Infections of skin in site of intervention

Treatment and study plan

Bimatoprost 0.03% solution

Drug

Topical Bimatoprost 0.03% solution

Other names: Topical treatment of skin lesions

CO2 Fractional Laser

Device

CO2 fractional laser treatment

Other names: laser treratment

Primary outcomes

  1. Hair regrowth

    Time frame: 9 weeks

    Efficacy of treatment assessed using a prognostic scoring system proposed by Mcdonald Hull and Norris for density, pigmentation, and texture of growing hair.

    Grade 1 - Regrowth of vellus hair Grade 2 - Regrowth of sparse pigmented terminal hair Grade 3 - Regrowth of terminal hair with patches of alopecia Grade 4 - Regrowth of terminal hair on scalp

Secondary outcomes

  1. Side effects

    Time frame: 9 weeks

    The patients were asked about any side effects noticed every session by questionnaire.

    The patient satisfaction scale: - the patients were asked at final visit to rate the overall satisfaction according to whether the patient was not satisfied, slightly satisfied, satisfied or very satisfied.

    The patients were asked to report any complications as; erythema, pain, ulceration, burning sensation, ecchymosis, infection, post-inflammatory hyperpigmentation or any allergic manifestations.

  2. Follow up assessment

    Time frame: 9 weeks

    The patients were followed up 3 weeks after the end of treatment sessions to detect any recurrence, complications or worsening of the lesions & final results of treatment.

Sponsors and collaborators

Lead sponsor

Ahmed Hassan Nouh MD

Other

Registry information

Official study title

Efficacy of Combined CO2 Fractional Laser With Bimatoprost 0.03% in Treatment of Alopecia Areata

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 31, 2022
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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