Hidradenitis suppurativa Skin and Connective Tissue Diseases Hidradenitis suppurativa
Conditions
Interventions
1. Oral doxycycline 200 mg OD for 6 months initially
2. Oral clindamycin and rifampicin both 300 mg BD as a combined course for 10 weeks
3. Laser treatment
4. Deroofing of sinus tracts
5. Conventional
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults at least 18 years old with active HS of any severity 2. Diagnosis confirmed by recruiting clinician with experience of HS care 3. HS not adequately controlled by current treatment 4. At least one of the five study interventions is appropriate for participant’s care
Exclusion criteria
Exclusion criteria: 1. Unable or unwilling to give informed consent 2. Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants who are eligible, and hypothetically willing, to use the different treatment options, measured using screening log at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants choosing each of the study interventions, with reasons for their choices, measured using descriptive statistics of each group membership for each intervention at baseline/month 0 2. Proportion of participants who switch treatments during the study follow-up period, with reasons for switch, measured using questionnaires during the study follow-up period 3. Treatment fidelity measured using questionnaire at 3, 6, 9 and 12 months 4. Loss to follow-up rates measured using percentage of consented participants failing to attend appointments over 12 months 5. Efficacy outcome estimates after 6 months’ of follow up to inform outcome measure instruments’ responsiveness (minimum important difference, MID): 5.1. Pain measured using a numeric rating scale at the baseline appointment and then on a daily basis for the first 12 weeks following treatment commencement via mobile telephone text message 5.2. HS-specific quality of life measured using HiSQOL 5.3. Global assessment (average change over time estimation) 5.4. Progression of course (flare frequency) (average change over time estimation) 5.5. Physical signs (average change over time estimation) 5.6. Symptoms (drainage resulting in need for dressings and fatigue) (average change over time estimation) 5.7. Generic quality of life measured using EQ-5D The researchers will report completeness of each outcome at each timepoint (0, 3, 6, 9 and 12 months) | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactJanine Bates
Outcome results
None listed