Back to resultsMultimodal Optical Imaging for Pretreatment Evaluation for Cutaneous Microparticle Delivery
Primary Purpose
Acne Vulgaris, Microparticles
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Adapalene-Benzoyl Peroxide Gel 0.1-2.5%
Sponsored by
About this trial
This is an interventional basic science trial for Acne Vulgaris focused on measuring Optical Coherence Tomography, Reflectance Confocal Microscopy, Gold microparticles, Adapalene, Benzoyl Peroxide
Eligibility Criteria
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
Sites / Locations
- Bispebjerg Hospital, Department of Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acne patients
Arm Description
Outcomes
Primary Outcome Measures
Change in gold microparticle delivery after 6 weeks of pretreatment evaluated by RCM
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03573115
First Posted
May 2, 2018
Last Updated
March 18, 2022
Sponsor
Merete Haedersdal
Collaborators
Sebacia, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03573115
Brief Title
Multimodal Optical Imaging for Pretreatment Evaluation for Cutaneous Microparticle Delivery
Official Title
Multimodal Optical Imaging for Pretreatment Evaluation for Cutaneous Microparticle Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
July 18, 2018 (Actual)
Study Completion Date
August 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Merete Haedersdal
Collaborators
Sebacia, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris, Microparticles
Keywords
Optical Coherence Tomography, Reflectance Confocal Microscopy, Gold microparticles, Adapalene, Benzoyl Peroxide
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acne patients
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Adapalene-Benzoyl Peroxide Gel 0.1-2.5%
Other Intervention Name(s)
Seb-250
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in gold microparticle delivery after 6 weeks of pretreatment evaluated by RCM
Description
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.
Time Frame
baseline and after 6 weeks of study
Title
Change in gold microparticle delivery after 6 weeks of pretreatment evaluated by OCT
Description
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.
Time Frame
baseline and after 6 weeks of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bispebjerg Hospital, Department of Dermatology
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Multimodal Optical Imaging for Pretreatment Evaluation for Cutaneous Microparticle Delivery
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