Facial acne vulgaris lesions after pretreatment with topical retinoid MedDRA version: 20.0 Level: LLT Classification code 10000519 Term: Acne vulgaris System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Epiduo
Product Name: Epiduo
Product Code: PL 10590/0057
Pharmaceutical Form: Gel
INN or Proposed INN: Adapalene
Other descriptive name: ADAPALENE
Concentration unit: mg/g milligram(s)/gra
Sponsors
Bispebjerg Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Denmark
Contacts
Public ContactDermatologisk forskningsafdeling
Bispebjerg Hospital
Outcome results
None listed