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Skin AbnormalitiesPhase 1NCT05923996

Fractional Co2 Laser Versus Microbotox Injection in the Treatment of Wide Facial Pores: A Split Face Comparative Study

A Phase 1 study testing microbotox and fractional carbon dioxide laser in people with Skin Abnormalities, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

1. Evaluation of fractional Co2 laser as a treatment option for wide pores in skin type (III - VI) 2. Evaluation of mesobotox as a new modality for improving wide pores appearance. 3. Comparison of both treatment modalities in treatment of enlarged pores. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Skin Abnormalities
What is being tested?
microbotox and fractional carbon dioxide laser
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
No sites listed yet
Study dates
1 Feb 2024to 1 Aug 2024
Phase
Phase 1
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 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patient with wide facial pores any grade.
  • Sex: male and female patient.
  • Age groups: patient above 18 and below 45 years old.
  • Co-operative patient.

Who cannot join

  • Patient below 18 and above 45 years old.
  • Patient with systemic illness or other dermatological disease.
  • Patient who receive topical treatment for facial wide pores in past month.
  • Patient who receive systemic treatment for facial wide pores in past 2 month.

Trial locations and contacts

No sites are listed yet.

Ahmed AE Ibrahim contact

01200889665

ahmedalaa12494@gmail.com

About this study

Official title: Fractional Carbon Dioxide Laser Versus Microbotox Injection in the Treatment of Wide Facial Pores: A Split Face Comparative Study

  1. Evaluation of fractional Co2 laser as a treatment option for wide pores in skin type (III - VI)
  2. Evaluation of mesobotox as a new modality for improving wide pores appearance.
  3. Comparison of both treatment modalities in treatment of enlarged pores.
Read the detailed description

Skin pores (SP), as they are called by laymen, are common and benign features mostly located on the face (nose, cheeks, etc) that generate many aesthetic concerns or complaints.

Enlarged skin pores refer to conditions that present with visible topographic changes of skin surfaces. Although not a medical concern, enlarged pores are a cosmetic concern for a large number of individuals.

Enlarged facial pores affect individuals of different ages, sexes, and races for which many seek treatment. The exact patho-mechanism of enlarged facial pores is not completely understood. Possible causes include genetic predisposition, seborrhea, aging, increased ultraviolet exposure and comedogenic products.

The treatment of dilated facial pores is difficult, and the ideal modality is not established yet. Many treatment modalities reduce facial pores' count and area, including oral and topical medications as well as different wavelengths of laser. Different ablative and non ablative lasers have been used in the treatment of dilated pores with variable outcomes.

The short-term results showed that treatment with low energy level CO2 fractional laser therapy could be a safe and effective option for patients with Fitzpatrick skin Types III and IV who are concerned with enlarged pores.

Microbotox also called mesobotox, is the injection of multiple microdroplets of diluted onabotulinum toxin A into the upper dermis. It has been previously used in study to decrease pore size and to improve skin texture.

Microbotox has been proved to be effective in improving the sheen and texture of the skin, as well as decreasing sweat and sebum production and enlarged pores as it causes atrophy of sebaceous glands, which subsequently causes tightening of the skin envelope.

Being tested
microbotox, fractional carbon dioxide laser
Medical subject headings
Skin Abnormalities

What participants receive

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

  • microbotoxDrug

    Also called botulinum toxin type A

    Will be treated by single session of microbotox injection

  • fractional carbon dioxide laserRadiation

    Two sessions of the fractional CO2 laser on this side of the face at 4-weeks intervals

Study groups in NCT05923996
Study groupRoleWhat they receive
Microbotox injectionExperimental21 Egyptian patients with wide facial pores will be treated in a split-face manner. In this side of the face will received single session of microbotox injection contains 20 units of botulinum toxin A.
Receives: Drug: microbotox
Fractional carbon dioxide laser in second side of the faceExperimental21 Egyptian patients with wide facial pores will be treated in a split-face manner. In this side will be treated by Two sessions of the fractional CO2 laser on this side of the face at 4-weeks intervals.
Receives: Radiation: fractional carbon dioxide laser

What is being measured

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

  1. pore score

    evaluation of facial pores after four weeks of second session by pore score: score "0" referred to absence of visible pores. score "1" referred to patients with visible pores. score "2" referred to patient with enlarged pores. score "3" referred to patient with black heads when embedded on facial pores.

    Measured: three months

  2. sebum score

    evaluation the degree of seborea after four weeks of second session by sebum score: 0 (dry skin)

    1. (mild oiliness)
    2. (moderate oiliness)
    3. (severe oiliness)

    Measured: three months

  3. Quartile improvement scale

    assessment the improvement after four weeks of first session and after four weeks of second session by Quartile improvement scale: 0 = No improvement

    1. = Minor/mild improvement (1%-25%)
    2. = Moderate improvement (26%-50%)
    3. = Marked improvement (51%-75%)
    4. = Very significant improvement (76%-100%)

    Measured: three months

Secondary outcomes (1)

  1. Likert satisfaction scale

    1. = Very dissatisfied
    2. = Dissatisfied
    3. = Neither satisfied
    4. = Satisfied
    5. = Very satisfied

    Measured: three months

Timeline

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

  1. First posted29 Jun 2023
  2. Study start1 Feb 2024 (estimated)
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Aug 2024 (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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05923996
Sponsor's protocol ID
treatment of wide facial pores
Status last verified
Dec 2023
First submitted
14 Mar 2023
Last updated
27 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Flament F, Francois G, Qiu H, Ye C, Hanaya T, Batisse D, Cointereau-Chardon S, Seixas MD, Dal Belo SE, Bazin R. Facial skin pores: a multiethnic study. Clin Cosmet Investig Dermatol. 2015 Feb 16;8:85-93. doi: 10.2147/CCID.S74401. eCollection 2015.

    PubMed 25733918

  • Lee SJ, Seok J, Jeong SY, Park KY, Li K, Seo SJ. Facial Pores: Definition, Causes, and Treatment Options. Dermatol Surg. 2016 Mar;42(3):277-85. doi: 10.1097/DSS.0000000000000657.

    PubMed 26918966

  • Tarek E, Mostafa WZ, Allam RSHM, El-Samanoudy SI, Saadi DG. Short-pulsed and Q-switched ND-YAG laser with topical carbon versus fractional CO2 laser in the treatment of enlarged facial pores: A split-face comparative study. Lasers Surg Med. 2022 Feb;54(2):237-244. doi: 10.1002/lsm.23454. Epub 2021 Jul 13.

    PubMed 34255869

  • Eldeeb F, Wahid RM, Alakad R. Fractional carbon dioxide laser versus carbon-assisted Q-switched Nd: YAG laser in the treatment of dilated facial pores. J Cosmet Dermatol. 2021 Dec;20(12):3917-3923. doi: 10.1111/jocd.14311. Epub 2021 Jul 1.

    PubMed 34169628

  • Kwon HH, Choi SC, Lee WY, Jung JY, Park GH. Clinical and Histological Evaluations of Enlarged Facial Skin Pores After Low Energy Level Treatments With Fractional Carbon Dioxide Laser in Korean Patients. Dermatol Surg. 2018 Mar;44(3):405-412. doi: 10.1097/DSS.0000000000001313.

    PubMed 28902036

  • Ahmed El Attar Y, Nofal A. Microbotox for the treatment of wide facial pores: A promising therapeutic approach. J Cosmet Dermatol. 2021 May;20(5):1361-1366. doi: 10.1111/jocd.13675. Epub 2020 Sep 27.

    PubMed 32799408

  • Salem RM, Salah SAE, Ibrahim SE. Microbotox injection versus its topical application following microneedling in the treatment of wide facial pores: A split face comparative study. J Cosmet Dermatol. 2023 Apr;22(4):1249-1255. doi: 10.1111/jocd.15590. Epub 2023 Jan 6.

    PubMed 36606384

  • Sayed KS, Hegazy R, Gawdat HI, Abdel Hay RM, Ahmed MM, Mohammed FN, Allam R, Fahim A. The efficacy of intradermal injections of botulinum toxin in the management of enlarged facial pores and seborrhea: a split face-controlled study. J Dermatolog Treat. 2021 Nov;32(7):771-777. doi: 10.1080/09546634.2019.1708241. Epub 2020 Jan 3.

    PubMed 31865815

  • Saedi N, Petrell K, Arndt K, Dover J. Evaluating facial pores and skin texture after low-energy nonablative fractional 1440-nm laser treatments. J Am Acad Dermatol. 2013 Jan;68(1):113-8. doi: 10.1016/j.jaad.2012.08.041. Epub 2012 Oct 23.

    PubMed 23098639

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing microbotox and fractional carbon dioxide laser in people with Skin Abnormalities, 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 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: status not confirmed, as of the sponsor's last update on 27 Dec 2023. 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 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.

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 Ahmed AE Ibrahim (01200889665, ahmedalaa12494@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pore score (time frame: three months). The study lists 3 primary outcomes in all. 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 NCT05923996, which also lists 9 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 27 Dec 2023.

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