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

NCT04470466 | Completed FDA Device

• 1 other identifier: las49
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Lesion

Outcome Measures

Primary Outcomes (1)

• the percentage of decrease in size of enlarged facial pores assessed clinically and by dermoscopy

  2 months

Study Arms (2)

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

ACTIVE COMPARATOR

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

Fractional CO2 Laser

ACTIVE COMPARATOR

Device: fractional CO2 laser

Interventions

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

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

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

fractional CO2 laser DEVICE

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

Fractional CO2 Laser

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy

Cairo, 11562, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 4, 2020
• First Posted: July 14, 2020
• Study Start: July 19, 2020
• Primary Completion: October 12, 2020
• Study Completion: October 12, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)