Treatment of Acne Scars With Erbium:Yttrium Aluminum Garnet (Er:YAG) Laser Examined Under OCT

Acne Vulgaris Clinical Trial

Official title:

Treatment of Atrophic Facial Acne Scars With Er:YAG Laser Examined Under Optical Coherence Tomography

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03333759
• Other study ID #: 20170490
• Status: Withdrawn
• Phase: N/A
• Start date: August 2018
• Est. completion date: December 2018

Study information

• Verified date: July 2018
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is examining the effects of the 2940 nm Er:YAG on atrophic facial acne scars under optical coherence tomography in terms of blood flow, vessel shape, skin roughness, collagen content, and epidermal thickness.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Patients should be 18-90 years of age

2. Patients should have Fitzpatrick skin types of I-III

3. Patients should have at least mild acne

Exclusion Criteria:

1. The patient should not be receiving any additional systemic, topical, or intralesional treatment of the scars during the study

2. Pregnant or lactating females

3. Fitzpatrick skin type of IV-VI

4. A history of keloids or hypertrophic scars

5. Scleroderma

6. Photosensitivity

7. Botulinum toxin injection, facial laser resurfacing, chemical peels, fillers, or usage of oral retinoid within the last 6 months

8. Subjects with a known history of herpes simplex

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Device:
• Alma - Harmony XL Laser
The Erbium YAG laser at a 2940nm wavelength is used for ablative laser resurfacing as well as treating acne scars.

Locations

Country	Name	City	State
United States	Sylvester Comprehensive Cancer Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood flow	Optical coherence tomography (OCT) will be used to quantitatively measure changes in facial atrophic acne scars in terms of blood flow (proportion of signals with strong dynamic signal (%)/depth (mm)).	During 8 weeks
Primary	Change in epidermal thickness	Optical coherence tomography (OCT) will be used to quantitatively measure changes in facial atrophic acne scars in terms of epidermal thickness (mm).	During 8 weeks
Primary	Change in collagen content	OCT will be used to qualitatively measure changes in facial atrophic acne scars in terms of collagen content. Collagen content will be measured in terms of brightness of OCT scan. Areas of skin that contain collagen tend to be brighter (more white in color) whereas areas with less collagen content tend to be darker.	During 8 weeks
Primary	Change in skin roughness	OCT will be used to quantitatively measure changes in facial atrophic acne scars in terms of skin roughness (µm).	During 8 weeks
Secondary	The Patient Scar Assessment Scale	Scale (1-10) used to qualitatively monitor treatment and changes in scars by the patient.	During 8 weeks
Secondary	The Observer Scar Assessment Scale	Scale (1-10) used to qualitatively monitor treatment and changes in scars by the dermatologist.	During 8 weeks