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

Inclusion criteria

All subjects

• Healthy men and women
• 18-45 years of age at baseline
• Legally competent, able to give verbal and written consent
• Communicate in Danish verbally as well as in writing
• Women with negative pregnancy-test
• Subject in good general health, is willing to participate and able to give informed consent, and can comply with protocol requirements.
• Fitzpatrick skin phototype I-III

Acne skin

• Subject with previous or prior clinical diagnosis of acne vulgaris, IGA score 1-4
• 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)
• Each included patient with acne should represent at least 3 of 5 acne lesions
• Subject with in good general health, willing to participate and able to give informed consent, and able to comply with protocol requirements

Exclusion criteria

• Pregnant and lactating women
• Subject with a known allergy to gold, or any other ingredient in the microparticle suspension
• Individuals with skin diseases or skin lesions in the area of research interest will be excluded
• Subject with tattoo in the treatment area which may interfere with or confound evaluation of the study
• Subjects with severe acne (IGA 5) with imminent scarring potential, in the opinion of the investigator
• Subject with a history of keloids which is deemed clinically relevant in the opinion of the investigator
• 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.
• 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
• Subject having used oral retionoid therapy such as isotretionoin within 3 months prior to baseline.
• Subject having used topical retinoids, topical corticosteroids, topical antibiotics or combination therapy within 2 weeks of baseline
• Subject having used over-the-counter topical products containing azelaic acid, benzoyl peroxide, and/or salicylic acid within 1 week of baseline
• 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.
• Subject who has received an investigational drug or was treated with an investigational device within 30 days prior to baseline.