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

Primary Purpose

Skin Abnormalities

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
microbotox
fractional carbon dioxide laser
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Abnormalities

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Microbotox injection

    Fractional carbon dioxide laser in second side of the face

    Arm Description

    21 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.

    21 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.

    Outcomes

    Primary Outcome Measures

    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.
    sebum score
    evaluation the degree of seborea after four weeks of second session by sebum score: 0 (dry skin) (mild oiliness) (moderate oiliness) (severe oiliness)
    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 = Minor/mild improvement (1%-25%) = Moderate improvement (26%-50%) = Marked improvement (51%-75%) = Very significant improvement (76%-100%)

    Secondary Outcome Measures

    Likert satisfaction scale
    = Very dissatisfied = Dissatisfied = Neither satisfied = Satisfied = Very satisfied

    Full Information

    First Posted
    March 14, 2023
    Last Updated
    August 24, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05923996
    Brief Title
    Fractional Co2 Laser Versus Microbotox Injection in the Treatment of Wide Facial Pores: A Split Face Comparative Study
    Official Title
    Fractional Carbon Dioxide Laser Versus Microbotox Injection in the Treatment of Wide Facial Pores: A Split Face Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    April 1, 2024 (Anticipated)
    Study Completion Date
    May 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Evaluation of fractional Co2 laser as a treatment option for wide pores in skin type (III - VI) Evaluation of mesobotox as a new modality for improving wide pores appearance. Comparison of both treatment modalities in treatment of enlarged pores.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin Abnormalities

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    21 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Microbotox injection
    Arm Type
    Experimental
    Arm Description
    21 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.
    Arm Title
    Fractional carbon dioxide laser in second side of the face
    Arm Type
    Experimental
    Arm Description
    21 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.
    Intervention Type
    Drug
    Intervention Name(s)
    microbotox
    Other Intervention Name(s)
    botulinum toxin type A
    Intervention Description
    Will be treated by single session of microbotox injection
    Intervention Type
    Radiation
    Intervention Name(s)
    fractional carbon dioxide laser
    Intervention Description
    Two sessions of the fractional CO2 laser on this side of the face at 4-weeks intervals
    Primary Outcome Measure Information:
    Title
    pore score
    Description
    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.
    Time Frame
    three months
    Title
    sebum score
    Description
    evaluation the degree of seborea after four weeks of second session by sebum score: 0 (dry skin) (mild oiliness) (moderate oiliness) (severe oiliness)
    Time Frame
    three months
    Title
    Quartile improvement scale
    Description
    assessment the improvement after four weeks of first session and after four weeks of second session by Quartile improvement scale: 0 = No improvement = Minor/mild improvement (1%-25%) = Moderate improvement (26%-50%) = Marked improvement (51%-75%) = Very significant improvement (76%-100%)
    Time Frame
    three months
    Secondary Outcome Measure Information:
    Title
    Likert satisfaction scale
    Description
    = Very dissatisfied = Dissatisfied = Neither satisfied = Satisfied = Very satisfied
    Time Frame
    three months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed AE Ibrahim
    Phone
    01200889665
    Email
    ahmedalaa12494@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dalia A Ahmed, professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Howida O Mahmoud, lecturer
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25733918
    Citation
    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.
    Results Reference
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    PubMed Identifier
    26918966
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    34255869
    Citation
    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.
    Results Reference
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    PubMed Identifier
    34169628
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28902036
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32799408
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    36606384
    Citation
    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.
    Results Reference
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    PubMed Identifier
    31865815
    Citation
    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.
    Results Reference
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    PubMed Identifier
    23098639
    Citation
    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.
    Results Reference
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    Fractional Co2 Laser Versus Microbotox Injection in the Treatment of Wide Facial Pores: A Split Face Comparative Study

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