Multimodal Optical Imaging for Pretreatment Evaluation for Cutaneous Microparticle Delivery
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|ClinicalTrials.gov Identifier: NCT03573115|
Recruitment Status : Active, not recruiting
First Posted : June 29, 2018
Last Update Posted : October 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris Microparticles||Drug: Adapalene-Benzoyl Peroxide Gel 0.1-2.5%||Not Applicable|
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 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|
|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
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03573115
|Bispebjerg Hospital, Department of Dermatology|
|Copenhagen, Denmark, 2400|