Imaging of Pilosebaceous Units and Acne Lesions by RCM and OCT Confocal Microscopy and Optical Coherence Tomography

Acne Vulgaris Clinical Trial

Official title:

Imaging of Pilosebaceous Units and Acne Lesions by Reflectance Confocal Microscopy and Optical Coherence Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03524040
• Other study ID #: H-16042830
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: January 2018

Study information

• Verified date: May 2018
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study was to investigate if reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) could be used in combination to investigate the morphology of pilosebaceous units and acne lesions in healthy subjects and in acne patients.Furthermore, to investigate contrast effects, biodistribution and selective photothermolysis provided by gold microparticles and diode laser pulses, using RCM, OCT and histology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

All subjects

1. Healthy men and women

2. 18-45 years of age at baseline

3. Legally competent, able to give verbal and written consent

4. Communicate in Danish verbally as well as in writing

5. Women with negative pregnancy-test

6. Subject in good general health, is willing to participate and able to give informed consent, and can comply with protocol requirements.

7. Fitzpatrick skin phototype I-III

Acne skin

1. Subject with previous or prior clinical diagnosis of acne vulgaris, IGA score 1-4

2. Subjects with 1 - 75 inflammatory facial lesions on the cheek, forehead, and/or chin, with no more than 2 nodulocystic lesions (see Appendix II, table 4)

3. Each included patient with acne should represent at least 3 of 5 acne lesions

4. Subject with in good general health, willing to participate and able to give informed consent, and able to comply with protocol requirements

Exclusion Criteria:

1. Pregnant and lactating women

2. Subject with a known allergy to gold, or any other ingredient in the microparticle suspension

3. Individuals with skin diseases or skin lesions in the area of research interest will be excluded

4. Subject with tattoo in the treatment area which may interfere with or confound evaluation of the study

5. Subjects with severe acne (IGA 5) with imminent scarring potential, in the opinion of the investigator

6. Subject with a history of keloids which is deemed clinically relevant in the opinion of the investigator

7. Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or very severe acne requiring the continuation of systemic treatment during the study period.

8. Subject with active skin disease or excessive scarring that, in the opinion of the investigator, would impact the ability to administer the gold microparticles or use of OCT/RCM in the areas

9. Subject having used oral retionoid therapy such as isotretionoin within 3 months prior to baseline.

10. Subject having used topical retinoids, topical corticosteroids, topical antibiotics or combination therapy within 2 weeks of baseline

11. Subject having used over-the-counter topical products containing azelaic acid, benzoyl peroxide, and/or salicylic acid within 1 week of baseline

12. Subject having used light treatments including Intense Pulsed Light or other lasers, microdermabrasion or chemical peels in the treatment area within 3 weeks of baseline.

13. Subject who has received an investigational drug or was treated with an investigational device within 30 days prior to baseline.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Device:
• SEB-250
Gold microparticles (SEB-250) are massaged into 2 or 3 2x2 cm facial areas and exposed to 2 pulses from a diode laser

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen NV

Sponsors (2)

Lead Sponsor	Collaborator
Merete Haedersdal	Sebacia, Inc.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acne morphology	Qualitative assessment of acne lesions, pilosebaceous units and surrounding skin in RCM and OCT images	1 year
Primary	Gold microparticle biodistribution	Evaluation of gold microparticle biodistribution and contrast effects in RCM and OCT images	2 years