NCT05923996

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2024

Shorter than P25 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

March 14, 2023

Last Update Submit

December 23, 2023

Conditions

Skin Abnormalities

Outcome Measures

Primary Outcomes (3)

  • 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) 1. (mild oiliness) 2. (moderate oiliness) 3. (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 1. = Minor/mild improvement (1%-25%) 2. = Moderate improvement (26%-50%) 3. = Marked improvement (51%-75%) 4. = Very significant improvement (76%-100%)

    three months

Secondary Outcomes (1)

  • Likert satisfaction scale

    three months

Study Arms (2)

Microbotox injection

EXPERIMENTAL

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

Fractional carbon dioxide laser in second side of the face

EXPERIMENTAL

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

Interventions

microbotoxDRUG

Will be treated by single session of microbotox injection

Also known as: botulinum toxin type A
Microbotox injection
fractional carbon dioxide laserRADIATION

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

Fractional carbon dioxide laser in second side of the face

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 25733918BACKGROUND

  • 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.

    PMID: 26918966BACKGROUND

  • 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.

    PMID: 34255869BACKGROUND

  • 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.

    PMID: 34169628BACKGROUND

  • 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.

    PMID: 28902036BACKGROUND

  • 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.

    PMID: 32799408BACKGROUND

  • 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.

    PMID: 36606384BACKGROUND

  • 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.

    PMID: 31865815BACKGROUND

  • 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.

    PMID: 23098639BACKGROUND

MeSH Terms

Conditions

Skin Abnormalities

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Congenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Dalia A Ahmed, professor

    Assiut University

    STUDY DIRECTOR

  • Howida O Mahmoud, lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed AE Ibrahim

CONTACT

01200889665ahmedalaa12494@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

March 14, 2023

First Posted

June 29, 2023

Study Start

February 1, 2024

Primary Completion

June 1, 2024

Study Completion

August 1, 2024

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share