Short term clinical efficacy of topical treatment with clindamycin-benzoyl peroxide gel compared with clindamycin lotion in mild to moderate Hidradenitis Suppurativa
- Conditions
- acne inversaverneuil's disease10040798
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The frequency of flares (active lesions) during 12 weeks. </p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Clinical efficacy after 12 weeks.<br /><br>2. Skin-related pain after 12 weeks.<br /><br>3. Pruritus after 12 weeks.<br /><br>4. Treatment satisfaction after 12 weeks and after an additional 4 week<br /><br>follow-up.<br /><br>5. Sustained efficacy after 4 week follow-up after end of treatment.<br /><br>6. Diversity of the microbiome at baseline, 12 weeks and after an additional 4<br /><br>week follow-up.<br /><br>7. Resistance pattern at baseline, 12 weeks and after an additional 4 week<br /><br>follow-up.<br /><br>8. The short-term safety and tolerability of both treatments after 12 weeks.</p><br>