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

December 23, 2023 updated by: Ahmed Alaa Eldin Ibrahim, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: microbotox
Will be treated by single session of microbotox injection
Other Names:
  • botulinum toxin type A
Experimental: 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.
Radiation: fractional carbon dioxide laser
Two sessions of the fractional CO2 laser on this side of the face at 4-weeks intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quartile improvement scale
Time Frame: three months

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%)
three months
pore score
Time Frame: three months
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
Time Frame: three months

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)
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Likert satisfaction scale
Time Frame: three months
  1. = Very dissatisfied
  2. = Dissatisfied
  3. = Neither satisfied
  4. = Satisfied
  5. = Very satisfied
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Dalia A Ahmed, professor, Assiut University
  • Principal Investigator: Howida O Mahmoud, lecturer, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

June 19, 2023

First Posted (Actual)

June 29, 2023

Study Record Updates

Last Update Posted (Actual)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 23, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • treatment of wide facial pores

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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