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

NCT ID: NCT05923996

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Skin Abnormalities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Microbotox injection

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.

Group Type EXPERIMENTAL

microbotox

Intervention Type DRUG

Will be treated by single session of microbotox injection

Fractional carbon dioxide laser in second side of the face

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.

Group Type EXPERIMENTAL

fractional carbon dioxide laser

Intervention Type RADIATION

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

Interventions

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microbotox

Will be treated by single session of microbotox injection

Intervention Type DRUG

fractional carbon dioxide laser

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

Intervention Type RADIATION

Other Intervention Names

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botulinum toxin type A

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Alaa Eldin Ibrahim

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dalia A Ahmed, professor

Role: STUDY_DIRECTOR

Assiut University

Howida O Mahmoud, lecturer

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

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Ahmed AE Ibrahim

Role: CONTACT

Phone: 01200889665

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 25733918 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26918966 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34255869 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34169628 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28902036 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32799408 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36606384 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31865815 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23098639 (View on PubMed)

Other Identifiers

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treatment of wide facial pores

Identifier Type: -

Identifier Source: org_study_id