Clinical trial NCT05923996: 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
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Skin Abnormalities
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: pore score
timeFrame: three months
measure: sebum score
timeFrame: three months
measure: Quartile improvement scale
timeFrame: three months
Secondary outcomes:
measure: Likert satisfaction scale
timeFrame: three months
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Dalia A Ahmed, professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Howida O Mahmoud, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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