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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Skin Abnormalities

Intervention / Treatment
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* Drug: microbotox
* Radiation: fractional carbon dioxide laser


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microbotox injection<br>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. | Drug: microbotox<br>* Will be treated by single session of microbotox injection<br>* Other names: botulinum toxin type A;|
| Experimental: Fractional carbon dioxide laser in second side of the face<br>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. | Radiation: fractional carbon dioxide laser<br>* Two sessions of the fractional CO2 laser on this side of the face at 4-weeks intervals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | three months | 
| 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) | three months | 
| 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%) | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likert satisfaction scale | = Very dissatisfied = Dissatisfied = Neither satisfied = Satisfied = Very satisfied | three months |