se of two imaging technologies for pretreatment evaluation for microparticle delivery to the ski

Phase 1

• Conditions: Facial acne vulgaris lesions after pretreatment with topical retinoid; MedDRA version: 20.0Level: LLTClassification code 10000519Term: Acne vulgarisSystem Organ Class: 100000004858; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2017-002975-25-DK
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-20
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

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 potential1 must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 benzoylperoxide 4 weeks prior to baseline

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: We aim at investigating if pretreatment enhances delivery of gold microparticles to the skin. ;Secondary Objective: To investigate the bio-distribution of gold microparticles in pretreated skin and compare it to the bio-distribution in non-pretreated skin by non-invasive imaging techniques ;Primary end point(s): To investigate how pretreatment with a topical retinoid affects delivery of gold microparticles into the skin of acne patients. ;Timepoint(s) of evaluation of this end point: Baseline and at 3rd visit after 6 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To investigate how the bio-distribution of gold microparticles in pretreated skin and compare it to the bio-distribution in non-pretreated skin by non-invasive imaging techniques ;Timepoint(s) of evaluation of this end point: Baselne and at 3rd visit after 6 weeks of treatment.