Short Pulse and Q-switched ND-YAG Laser With Topical Carbon Versus Fractional CO2 Laser for Enlarged Facial Pores

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04470466

Collaborator

(none)

Enrollment

Location

Arms

2.8

Actual Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Facial pores are visible topographic features of the skin that reflect openings of pilosebaceous follicles, that may be enlarged causing distress to some individuals. Many patients desire treatment for this condition, which can be an early sign of skin aging. Therapeutic modalities include intense pulsed light, radiofrequency, dermabrasion, oral and topical retinoids, as well as chemical peeling. Lasers, as fractional CO2, short pulse and Q-switched Nd-YAG, can potentially be used in treatment of wide pores.

This study aims at the assessment and comparison of therapy with short pulsed and Q-switched Nd-YAG laser plus topical carbon with fractional CO2 laser in the management of wide facial pores.

Condition or Disease	Intervention/Treatment	Phase
Skin Lesion	Device: short pulse and Q-switched ND-YAG laser with topical carbon Device: fractional CO2 laser	N/A

Detailed Description

topical carbon cream will be applied to one side of the face in patients with wide facial pores, followed by 2 passes of short pulse 1064 ND:YAG laser, then one pass of Q-switched ND-YAG laser.

fractional CO2 laser will be performed to the other half of the face. the patients will receive 2 treatment sessions

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Short Pulse and Q-switched ND-YAG Laser With Topical Carbon Versus Fractional CO2 Laser in Treatment of Enlarged Facial Pores: A Split-face Comparative Study

Actual Study Start Date :

Jul 19, 2020

Actual Primary Completion Date :

Oct 12, 2020

Actual Study Completion Date :

Oct 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: short pulse and Q-switched ND-YAG laser with topical carbon	Device: short pulse and Q-switched ND-YAG laser with topical carbon application of topical carbon cream, followed by two passes of short pulse 1064 ND-YAG, then one pass of Q-switched 1064 ND-YAG on one side of the face
Active Comparator: Fractional CO2 Laser	Device: fractional CO2 laser single pass of fractional CO2 laser on the other side of the face

Arm

Intervention/Treatment

Active Comparator: short pulse and Q-switched ND-YAG laser with topical carbon

Device: short pulse and Q-switched ND-YAG laser with topical carbon

application of topical carbon cream, followed by two passes of short pulse 1064 ND-YAG, then one pass of Q-switched 1064 ND-YAG on one side of the face

Active Comparator: Fractional CO2 Laser

Device: fractional CO2 laser

single pass of fractional CO2 laser on the other side of the face

Outcome Measures

Primary Outcome Measures

the percentage of decrease in size of enlarged facial pores assessed clinically and by dermoscopy [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants who are more than 18 years old with the large facial pores and are aware of their problem and seeking treatment

Exclusion Criteria:

• Previous laser therapy, chemical peeling, microdermabrasion or cosmetic procedure for the face.
Patients with any contraindication to laser therapy such as photosensitive diseases, skin malignancies, patients on oral retinoids.
Keloid-forming tendency.
Local or systemic treatment for skin pores in the previous 3 months
Connective tissue disease or the use of immunosuppressive medications.
Pregnancy.
Present or past history of herpes labialis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr Alainy	Cairo		Egypt	11562

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dina Saadi, principal investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT04470466

Other Study ID Numbers:

las49

First Posted:

Jul 14, 2020

Last Update Posted:

Oct 19, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Study Results

No Results Posted as of Oct 19, 2020