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

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ClinicalTrials.gov Identifier: NCT03524040
Recruitment Status : Completed
First Posted : May 14, 2018
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
Sebacia, Inc.
Information provided by (Responsible Party):
Merete Haedersdal, Bispebjerg Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Device: SEB-250 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Imaging of Pilosebaceous Units and Acne Lesions by Reflectance Confocal Microscopy and Optical Coherence Tomography
Actual Study Start Date : December 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Acne patients
Application of gold microparticles to 2-3 facial areas
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

Experimental: Heatlhy volunteers
Application of gold microparticles to 2 facial areas
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




Primary Outcome Measures :
  1. Acne morphology [ Time Frame: 1 year ]
    Qualitative assessment of acne lesions, pilosebaceous units and surrounding skin in RCM and OCT images

  2. Gold microparticle biodistribution [ Time Frame: 2 years ]
    Evaluation of gold microparticle biodistribution and contrast effects in RCM and OCT images



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524040


Locations
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Denmark
Bispebjerg Hospital
Copenhagen NV, Denmark, 2400
Sponsors and Collaborators
Merete Haedersdal
Sebacia, Inc.

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Responsible Party: Merete Haedersdal, DMSc, PhD, MD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03524040     History of Changes
Other Study ID Numbers: H-16042830
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Merete Haedersdal, Bispebjerg Hospital:
Selective Photothermolysis
Reflectance Confocal Microscopy
Optical Coherence Tomography
Pilosebaceous Unit
Gold Microparticles

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases