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Alopecia AreataPhase 1/2NCT05600673

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

A Phase 1/2 study testing Bimatoprost 0.03% solution and CO2 fractional laser in people with Alopecia Areata, run by Ahmed Hassan Nouh MD at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 to 55 years
Conditions the study is for
Alopecia Areata
What is being tested?
Bimatoprost 0.03% solution and CO2 fractional laser
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
1 Jan 2019to 1 May 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 55 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • AL-Azhar University Hospital

    Cairo, 11865

Other trials in Egypt

About this study

Official title: Efficacy of Combined CO2 Fractional Laser With Bimatoprost 0.03% in 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.

Read the detailed description

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.

Conditions
Alopecia Areata
Being tested
Bimatoprost 0.03% solution, CO2 fractional laser
Keywords
Alopecia areata, Bimatoprost, CO2 Fractional Laser
Medical subject headings
Alopecia Areata

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bimatoprost 0.03% solutionDrug

    Also called Topical treatment of skin lesions

    Topical Bimatoprost 0.03% solution

  • CO2 fractional laserDevice

    Also called laser treratment

    CO2 fractional laser treatment

Study groups in NCT05600673
Study groupRoleWhat they receive
Bimatoprost + CO2ExperimentalEach patient received three CO2 fractional laser sessions 3 weeks apart with immediate and subsequent daily Bimatoprost 0.03%,1 drop for each 1cm².
Receives: Drug: Bimatoprost 0.03% solution; Device: CO2 fractional laser
CO2Active comparatorEach patient received only three CO2 fractional laser sessions 3 weeks apart
Receives: Device: CO2 fractional laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hair regrowth

    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

    Measured: 9 weeks

Secondary outcomes (2)

  1. Side effects

    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.

    Measured: 9 weeks

  2. Follow up assessment

    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.

    Measured: 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2022
  2. Study start1 Jan 2019
  3. Primary completion30 Jan 2021
  4. Study completion1 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
In this design, subjects are randomized to 2 study arms and each study arm will be allocated a different intervention. After randomization each participant will stay in their assigned treatment arm for the duration of the study.
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05600673
Sponsor's protocol ID
AlAzharUE
Status last verified
Oct 2022
First submitted
22 Oct 2022
Last updated
31 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Al-Dhalimi MA, Al-Janabi MH, Abd Al Hussein RA. The Use of a 1,540 nm Fractional Erbium-Glass Laser in Treatment of Alopecia Areata. Lasers Surg Med. 2019 Dec;51(10):859-865. doi: 10.1002/lsm.23133. Epub 2019 Jul 18.

    PubMed 31321800

  • Choi YM, Diehl J, Levins PC. Promising alternative clinical uses of prostaglandin F2alpha analogs: beyond the eyelashes. J Am Acad Dermatol. 2015 Apr;72(4):712-6. doi: 10.1016/j.jaad.2014.10.012. Epub 2015 Jan 16.

    PubMed 25601618

  • Faghihi G, Andalib F, Asilian A. The efficacy of latanoprost in the treatment of alopecia areata of eyelashes and eyebrows. Eur J Dermatol. 2009 Nov-Dec;19(6):586-7. doi: 10.1684/ejd.2009.0766. Epub 2009 Jul 21.

    PubMed 19620039

  • El-Husseiny R, Elframawy S, Abdallah M. Comparative study between fractional carbon dioxide laser vs intralesional steroid injection in treatment of alopecia areata. Dermatol Ther. 2020 Jul;33(4):e13742. doi: 10.1111/dth.13742. Epub 2020 Jul 9.

    PubMed 32478930

  • Kim WS, Lee HI, Lee JW, Lim YY, Lee SJ, Kim BJ, Kim MN, Song KY, Park WS. Fractional photothermolysis laser treatment of male pattern hair loss. Dermatol Surg. 2011 Jan;37(1):41-51. doi: 10.1111/j.1524-4725.2010.01833.x. Epub 2010 Dec 28.

    PubMed 21199096

  • Smith S, Fagien S, Whitcup SM, Ledon F, Somogyi C, Weng E, Beddingfield FC 3rd. Eyelash growth in subjects treated with bimatoprost: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study. J Am Acad Dermatol. 2012 May;66(5):801-6. doi: 10.1016/j.jaad.2011.06.005. Epub 2011 Sep 6.

    PubMed 21899919

  • Alkhalifah A, Alsantali A, Wang E, McElwee KJ, Shapiro J. Alopecia areata update: part II. Treatment. J Am Acad Dermatol. 2010 Feb;62(2):191-202, quiz 203-4. doi: 10.1016/j.jaad.2009.10.031.

    PubMed 20115946

  • Vila TO, Camacho Martinez FM. Bimatoprost in the treatment of eyelash universalis alopecia areata. Int J Trichology. 2010 Jul;2(2):86-8. doi: 10.4103/0974-7753.77511.

    PubMed 21712909

  • Wang W, Gegentana, Tonglaga, Bagenna, Li Y. Treatment of alopecia areata with nonablative fractional laser combined with topical minoxidil. J Cosmet Dermatol. 2019 Aug;18(4):1009-1013. doi: 10.1111/jocd.12883. Epub 2019 Jun 6.

    PubMed 31245963

  • Zaher H, Gawdat HI, Hegazy RA, Hassan M. Bimatoprost versus Mometasone Furoate in the Treatment of Scalp Alopecia Areata: A Pilot Study. Dermatology. 2015;230(4):308-13. doi: 10.1159/000371416. Epub 2015 Mar 4.

    PubMed 25765294

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Bimatoprost 0.03% solution and CO2 fractional laser in people with Alopecia Areata, run by Ahmed Hassan Nouh MD at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hair regrowth (time frame: 9 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05600673, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.

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