Hidradenitis Suppurativa MedDRA version: 20.0 Level: LLT Classification code 10020041 Term: Hidradenitis suppurativa System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Duac gel
Product Name: DUAC
Product Code: RVG 31531
Pharmaceutical Form: Gel
Sponsors
Department of Dermatology, Erasmus University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years. 2. Mild to moderate HS defined as a HS-PGA of 2 or 3 with at least 2 lesions in each eligible anatomical area. 3. A diagnosis of HS for more than six months prior to baseline. 4. Able and willing to give written informed consent and to comply with the study requirements 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Contraindication for treatment with either clindamycin lotion 1% or clindamycin 1%/benzoyl peroxide 5% gel. 2. Superinfection of HS lesions. 3. Current or recurrent clinically significant skin condition in the HS treatment area other than HS. 4. Presence of other uncontrolled clinically significant major disease. 5. Pregnant and lactating women. 6. The use of systemic antibiotics 14 days prior to inclusion. 7. The use of topical antibiotics or Resorcinol cream in the eligible areas 14 days prior to inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the frequency of flares (active lesions) over the course of 12 weeks of treatment. ; Secondary Objective: - To assess the clinical efficacy after 12 weeks of treatment. - To assess the skin-related pain after 12 weeks of treatment. - To assess the pruritus after 12 weeks of treatment. - To assess treatment satisfaction after 12 of treatment. - To assess the sustained efficacy and treatment satisfaction after 4 weeks of follow-up after end of treatment. - To evaluate the effect of both treatments on the diversity of the microbiome after 12 weeks of treatment and 4 weeks of follow-up after end of treatment. - To evaluate the change in resistance pattern after 12 weeks of treatment and 4 weeks of follow-up after end of treatment. - To assess the short-term safety and tolerability of both treatments. ;Primary end point(s): The frequency of flares (active lesions) ;Timepoint(s) of evaluation of this end point: Over the course of 12 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Clinical efficacy 2. Skin-related pain 3. Pruritus 4. Treatment satisfaction 5. Sustained efficacy 6. Diversity of the microbiome 7. Resistance pattern 8. The short-term safety and tolerability of both treatments ;Timepoint(s) of evaluation of this end point: Secondary endpoints 1,2,3, 4, 6, 7, and 8 will be measured after 12 weeks of treatment. Endpoint 4, 5, 6, and 7 will also be measured after 4 weeks of follow-up after end of treatment. | — |
Countries
Netherlands
Contacts
Public ContactE.P. Prens
Erasmus University Medical Center, Department of Dermatology
Outcome results
None listed