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AzTrials

VitiligoPhase 4NCT04577027

Effect Of Topical Prostaglandin F2α Analogs,Fractional CO2 Laser, Excimer Laser Or Their Combination In Treatment Of Vitiligo

A Phase 4 study testing Topical travoprost 0.004% solution, Fractional CO2 laser and Excimer laser in people with Vitiligo and Excimer Laser, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Vitiligo is a chronic disease with an unpredictable clinical course, characterized by the appearance of white macules and patches on the skin and mucous membranes due to the disappearance of melanocytes in the affected area. It affects approximately 0.5% - 2% of the population worldwide and may occur at any age. Read more about this study

Who is it for?
Ages 12 to 60 years
Conditions the study is for
Vitiligo, Excimer Laser, Fractional CO2 Laser
What is being tested?
Topical travoprost 0.004% solution, Fractional CO2 laser and Excimer laser
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
1 Jan 2021to 1 Apr 2022
Phase
Phase 4
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 12 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients older than 12 years.
  • Patients with generalized non-segmental vitiligo.
  • No previous treatment for vitiligo in the last 1 month.
  • Patients who were unresponsive to medical treatment or photo therapy for at least 3 months.

Who cannot join

  • Patients with sensitivity to travoprost.
  • Patients with photosensitivity.
  • Patients with history or active skin cancer.
  • No other dermatological or systemic diseases.
  • Active infections .
  • Pregnant or lactating females.

Trial locations and contacts

No sites are listed yet.

Hatem Zidan, Prof.DR contact

01003420217

hzma03@yahoo.com

Yasmin Tawfik, DR contact

About this study

Official title: Safety And Efficacy Of Topical Prostaglandin F2α Analogs In Combination With Fractional CO2 Laser And 308 Excimer Light In Treatment Of Vitiligo

Vitiligo is a chronic disease with an unpredictable clinical course, characterized by the appearance of white macules and patches on the skin and mucous membranes due to the disappearance of melanocytes in the affected area.

It affects approximately 0.5% - 2% of the population worldwide and may occur at any age.

Vitiligo is caused by a dynamic interplay between genetic and environmental risks that initiates an autoimmune attack on melanocytes in the skin.

Read the detailed description

The treatment of vitiligo has been a challenge for dermatologists. Recent reports have highlighted darkening of iris, and eyelashes and periocular hyperpigmentation induced by prostaglandin F2α analogues used for the treatment of glaucoma (as travoprost). Extrapolating these findings in the treatment of vitiligo.

The beneficial effect of fractional CO2 laser on vitiligo is postulated to come from the release of cytokines and growth factors that act as mitogens for melanogenesis . The preceding laser also alters the skin barrier, which results in increased penetration of topical drugs and ultraviolet (UV) radiation.

308 nm excimer laser is a monochromatic, target type treatment and allows the delivery of higher fluences to the lesions and avoids damage to the surrounding normal skin resulting in a faster and more effective pigmentation with minimal side effects.

Being tested
Topical travoprost 0.004% solution, Fractional CO2 laser, Excimer laser, Combination therapy, Excimer laser and travoprost
Medical subject headings
Vitiligo

What participants receive

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

  • Topical travoprost 0.004% solutionDrug

    30 Patches treated with Topical Travoprost 0.004% solution: Topical travoprost 0.004% solution once daily (1 drop for each 2.5 x 2.5 cm2) for 3 months.

  • Fractional CO2 laserDevice

    30 Patches treated with Fractional CO2 laser: Fractional CO2 laser sessions twice monthly for 3 months, parameters settings as follows: Energy\ dot 100mj, pulse duration 5ms, density level 17, pattern: array, depth level 1, 2 passes used

  • Excimer laserDevice

    30 Patches treated with Excimer laser: Excimer laser sessions will be repeated twice weekly on the selected patch only, The starting dose will be 200 mj /cm2, an increase of 100 mJ/cm2 in the following session if no erythema appears, an increase of 50 mJ/cm2 every session till the appearance of erythema that lasts 24 hours or more.

  • Combination therapyOther

    30 Patches treated with Combination therapy: Fractional CO2 laser twice per month followed by application of topical travoprost 0,004% daily and excimer laser twice weekly .

  • Excimer laser and travoprostOther

    30 Patches treated with Excimer laser twice weekly and topical travoprost once daily for 3 months

  • fractional CO2 laser and topical travoprostOther

    30 Patches treated with fractional CO2 laser twice monthly and topical travoprost once daily for 3 months

Study groups in NCT04577027
Study groupRoleWhat they receive
vitiligo patientsExperimentalThirty Patients complaining of generalized non segmental vitiligo will be recruited in this study. They will be chosen from the attendants of the out-patient clinics of Dermatology, Assiut university hospital. six patches will be selected in each patient.
Receives: Drug: Topical travoprost 0.004% solution; Device: Fractional CO2 laser; Device: Excimer laser; Other: Combination therapy; Other: Excimer laser and travoprost; Other: fractional CO2 laser and topical travoprost

What is being measured

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

  1. clinical improvement through VASI score

    VASI score will be calculated for each patient at start, every 4 weeks and 6 months after the last session.

    VASI = ∑ all treated sites [number of hand units] X [% residual depigmentation].

    Measured: 9 months

Secondary outcomes (3)

  1. Patients satisfaction

    according to the following scale:

    1. dissatisfied
    2. neutral
    3. somewhat satisfied
    4. moderately satisfied
    5. very satisfied

    Measured: 9 months

  2. percent of repigmentation

    The percent of repigmentation will be calculated every 4 weeks of treatment and 6 months after the last session by a scoring system .

    < 25% repigmentation (poor response). 25-50% repigmentation (fair response). 50-75% repigmentation (good response). > 75% repigmentation (excellent response).

    Measured: 9 months

  3. Histopathological evaluation

    Skin biopsy will be taken from the treated lesions after treatment, Hematoxylin and eosin-stained slides will be examined microscopically to evaluate the epidermal and dermal pathological changes: (1) evaluation of dermal perivascular inflammatory infiltrate density; (2) signs of pigmentation in the form of residual melanin in epidermis or dermal melanophages .

    Measured: 9 months

Timeline

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

  1. First posted6 Oct 2020
  2. Study start1 Jan 2021 (estimated)
  3. Primary completion1 Jan 2022 (estimated)
  4. Study completion1 Apr 2022 (estimated)

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04577027
Sponsor's protocol ID
FETV
Status last verified
Sep 2020
First submitted
26 Sep 2020
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fa Y, Lin Y, Chi XJ, Shi WH, Wang JL, Guo X, Geng JH, Liu HX, Zhang FR. Treatment of vitiligo with 308-nm excimer laser: our experience from a 2-year follow-up of 979 Chinese patients. J Eur Acad Dermatol Venereol. 2017 Feb;31(2):337-340. doi: 10.1111/jdv.13917. Epub 2016 Sep 19.

    PubMed 27538097

  • Kim HJ, Hong ES, Cho SH, Lee JD, Kim HS. Fractional Carbon Dioxide Laser as an "Add-on" Treatment for Vitiligo: A Meta-analysis with Systematic Review. Acta Derm Venereol. 2018 Feb 7;98(2):180-184. doi: 10.2340/00015555-2836.

    PubMed 29110015

  • Khattab FM, Abdelbary E, Fawzi M. Evaluation of combined excimer laser and platelet-rich plasma for the treatment of nonsegmental vitiligo: A prospective comparative study. J Cosmet Dermatol. 2020 Apr;19(4):869-877. doi: 10.1111/jocd.13103. Epub 2019 Sep 21.

    PubMed 31541597

  • Wong L, Vasconez HC. Patient satisfaction after Nd:YAG laser-assisted lipolysis. Ann Plast Surg. 2011 May;66(5):561-3. doi: 10.1097/SAP.0b013e31820b3d1e.

    PubMed 21451378

  • Doghaim NN, Gheida SF, El-Tatawy RA, Mohammed Ali DA. Combination of fractional carbon dioxide laser with narrow band ultraviolet B to induce repigmentation in stable vitiligo: A comparative study. J Cosmet Dermatol. 2019 Feb;18(1):142-149. doi: 10.1111/jocd.12553. Epub 2018 Apr 30.

    PubMed 29707867

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Topical travoprost 0.004% solution, Fractional CO2 laser and Excimer laser in people with Vitiligo and Excimer Laser, run by Assiut University.

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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Hatem Zidan, Prof.DR (01003420217, hzma03@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical improvement through VASI score (time frame: 9 months). 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 NCT04577027, which also lists 5 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 22 Oct 2020.

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