Multimodal Optical Imaging for Pretreatment Evaluation for Cutaneous Microparticle Delivery

• Status: Unknown status
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate how pretreatment with a topical medication for acne affects application and delivery of gold microparticles to the skin in acne patients. In addition, the investigators want to investigate the biodistribution of gold microparticles in pretreated skin and compare this with the biodistribution of untreated skin using the non-invasive imaging techniques optical coherence tomography and reflectance confocal microscopy

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merete Haedersdal
• Collaborator: Sebacia, Inc.
• Treatments: Adapalene; Benzoyl Peroxide

Criteria

Inclusion Criteria:

1. Patients with a clinical diagnosis of acne vulgaris, IGA score 1-3

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. Fitzpatrick skin phototype I-III

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

7. Female subjects of childbearing potential (1) must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment

8. Female subjects must use one of following contraceptive techniques to be included in the study: intrauterine device (IUD) or hormonal contraception (birth control pills, birth control patch, birth control vaginal ring, birth control shot or birth control implant) (1) Female subjects are considered of childbearing potential unless they have been hysterectomized

Exclusion Criteria:

1. Subjects with a known allergy to gold microparticles or Epiduo®

2. Individuals with other skin disease than acne or skin lesions in the area of research interest

3. Subjects with tattoo in the treatment area which may interfere with or confound evaluation of the study

4. Subjects with moderate-severe to severe acne (IGA 4-5 and those presenting with either cysts or nodules) requiring continuation of systemic treatment during the study period

5. Subjects with a history of keloids which is deemed clinically relevant in the opinion of the investigator

6. Subjects 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

7. Pregnant and lactating women

8. Subjects who have received investigational drugs or were treated with investigational devices within 30 days prior to baseline

9. Treatment with oral retinoid 3 months prior to baseline

10. Treatment with systemic antibiotics 4 weeks prior to baseline

11. Topical retinoids, topical antibiotics or topical products with benzoyl peroxide 4 weeks prior to baseline