NCT03573115

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

May 2, 2018

Last Update Submit

March 18, 2022

Conditions

Acne VulgarisMicroparticles

Keywords

Optical Coherence TomographyReflectance Confocal MicroscopyGold microparticlesAdapaleneBenzoyl Peroxide

Outcome Measures

Primary Outcomes (2)

  • 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.

    baseline and after 6 weeks of study

  • 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.

    baseline and after 6 weeks of study

Study Arms (1)

Acne patients

EXPERIMENTAL
Drug: Adapalene-Benzoyl Peroxide Gel 0.1-2.5%

Interventions

Adapalene-Benzoyl Peroxide Gel 0.1-2.5%DRUG

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)

Also known as: Seb-250
Acne patients

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital, Department of Dermatology

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor, Consultant in Dermatology (DMSc, PhD, MD)

Study Record Dates

First Submitted

May 2, 2018

First Posted

June 29, 2018

Study Start

January 4, 2018

Primary Completion

July 18, 2018

Study Completion

August 1, 2020

Last Updated

March 21, 2022

Record last verified: 2022-03

Locations

DK(1)