Multimodal optical imaging for pretreatment evaluation for cutaneous microparticle delivery

Bispebjerg Hospital0 个研究点目标入组 15 人开始时间: 2017年9月20日最近更新: 2018年8月20日

适应症

试验速览

暂无简介。

•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

•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

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