Multimodal Optical Imaging for Pretreatment Evaluation for Cutaneous Microparticle Delivery

Sponsor

Merete Haedersdal (Other)

Overall Status

Completed

CT.gov ID

NCT03573115

Collaborator

Sebacia, Inc. (Industry)

Enrollment

Location

Arm

30.9

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris Microparticles	Drug: Adapalene-Benzoyl Peroxide Gel 0.1-2.5%	N/A

Detailed Description

Epiduo is a prescription gel that combines adapalene and benzoyl peroxide, two active substances for the external treatment of acne. Adapalene is a substance that resembles A-vitamin acid, which dissolves and prevents clog formation in the sebaceous glands. Benzoyl peroxide works by reducing the amount of bacteria while dissolving the clogs in the sebaceous glands. Epiduo is the only antibiotic-free combination for the treatment of acne.

Reflectance Confocal Microscopy (RCM) and Optical Coherence Tomography (OCT) are non-invasive imaging technologies allowing for imaging of the upper skin layers. Gold microparticles have been shown to have a contrast effect on the images. In addition to the contrast effect on images, gold microparticles have proven to be effective in the treatment of skin disease acne. The treatment with gold microparticles uses a combination of the gold microparticles and a laser. The microparticles consist of very small particles of silica, surrounded by a shell of gold. These two components of the microparticles are selected from their way of absorbing light from a laser. The particles absorb the light from the laser and are thus heated. The surrounding skin can not absorb the light and therefore will maintain its normal temperature.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Multimodal Optical Imaging for Pretreatment Evaluation for Cutaneous Microparticle Delivery

Actual Study Start Date :

Jan 4, 2018

Actual Primary Completion Date :

Jul 18, 2018

Actual Study Completion Date :

Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acne patients	Drug: Adapalene-Benzoyl Peroxide Gel 0.1-2.5% Topical gold microparticles (SEB-250) are delivered to two facial areas at baseline, patients are then prescribed a topical Adapalene-Benzoyl Peroxide Gel 0.1-2.5% for 6 weeks followed by a new exposure to gold microparticles (SEB-250) Other Names: Seb-250

Arm

Intervention/Treatment

Experimental: Acne patients

Drug: Adapalene-Benzoyl Peroxide Gel 0.1-2.5%

Topical gold microparticles (SEB-250) are delivered to two facial areas at baseline, patients are then prescribed a topical Adapalene-Benzoyl Peroxide Gel 0.1-2.5% for 6 weeks followed by a new exposure to gold microparticles (SEB-250)

Other Names:

Seb-250

Outcome Measures

Primary Outcome Measures

Change in gold microparticle delivery after 6 weeks of pretreatment evaluated by RCM [baseline and after 6 weeks of study]
Quantitative evaluation of fraction of follicles with gold microparticles at baseline and after 6 weeks of study. Change in fraction of follicles with gold will be assessed.
Change in gold microparticle delivery after 6 weeks of pretreatment evaluated by OCT [baseline and after 6 weeks of study]
Quantitative evaluation of depth of gold in hair follicles at baseline and after 6 weeks of pretreatment, measured in um. Change in depth will be assessed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with a clinical diagnosis of acne vulgaris, IGA score 1-3
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
Fitzpatrick skin phototype I-III
Subjects in good general health, willing to participate and able to give informed consent, and can comply with protocol requirements
Female subjects of childbearing potential (1) must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment
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:

Subjects with a known allergy to gold microparticles or Epiduo®
Individuals with other skin disease than acne or skin lesions in the area of research interest
Subjects with tattoo in the treatment area which may interfere with or confound evaluation of the study
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
Subjects with a history of keloids which is deemed clinically relevant in the opinion of the investigator
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
Pregnant and lactating women
Subjects who have received investigational drugs or were treated with investigational devices within 30 days prior to baseline
Treatment with oral retinoid 3 months prior to baseline
Treatment with systemic antibiotics 4 weeks prior to baseline
Topical retinoids, topical antibiotics or topical products with benzoyl peroxide 4 weeks prior to baseline