Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

Multimodal Optical Imaging for Pretreatment Evaluation for Cutaneous Microparticle Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03573115
Recruitment Status : Active, not recruiting
First Posted : June 29, 2018
Last Update Posted : October 25, 2019
Sebacia, Inc.
Information provided by (Responsible Party):
Merete Haedersdal, Bispebjerg Hospital

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% Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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 : January 4, 2018
Actual Primary Completion Date : July 18, 2018
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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 Name: Seb-250

Primary Outcome Measures :
  1. Change in gold microparticle delivery after 6 weeks of pretreatment evaluated by RCM [ Time Frame: 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.

  2. Change in gold microparticle delivery after 6 weeks of pretreatment evaluated by OCT [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT03573115

Layout table for location information
Bispebjerg Hospital, Department of Dermatology
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Merete Haedersdal
Sebacia, Inc.

Layout table for additonal information
Responsible Party: Merete Haedersdal, Clinical Professor, Consultant in Dermatology (DMSc, PhD, MD), Bispebjerg Hospital Identifier: NCT03573115    
Other Study ID Numbers: EudraCT: 2017-002975-25
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Optical Coherence Tomography
Reflectance Confocal Microscopy
Gold microparticles
Benzoyl Peroxide
Additional relevant MeSH terms:
Layout table for MeSH terms
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents