Therefore the primary objective of this study is to evaluate the effect of twice daily application of topical clindamycin1%/benzoyl peroxide 5% gel compared with the standard treatment with topical clindamycin1% lotion on the frequency of active…
ID
Source
Brief title
Condition
- Skin appendage conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The frequency of flares (active lesions) during 12 weeks.
Secondary outcome
1. Clinical efficacy after 12 weeks.
2. Skin-related pain after 12 weeks.
3. Pruritus after 12 weeks.
4. Treatment satisfaction after 12 weeks and after an additional 4 week
follow-up.
5. Sustained efficacy after 4 week follow-up after end of treatment.
6. Diversity of the microbiome at baseline, 12 weeks and after an additional 4
week follow-up.
7. Resistance pattern at baseline, 12 weeks and after an additional 4 week
follow-up.
8. The short-term safety and tolerability of both treatments after 12 weeks.
Background summary
For mild and moderate HS topical clindamycin 1% is often prescribed for its
mild comedolytic and anti-inflammatory effects. The application of topical
clindamycin has been studied in a both a clinical trial and a randomized
control trail and was shown to be more effective compared with placebo. Topical
clindamycin 1%/benzoyl peroxide 5% gel, is often used in the treatment for acne
vulgaris. Benzoyl peroxide has antibacterial, anti-inflammatory, and
comedolytic properties. The combination of Clindamycin and benzoyl peroxide was
shown to be more effective compared with clindamycine alone. Moreover, the
addition of benzoyl peroxide 5% to clindamycin reduces clindamycin resistance
in acne vulgaris patients for Propionibacterium acnes.
Study objective
Therefore the primary objective of this study is to evaluate the effect of
twice daily application of topical clindamycin1%/benzoyl peroxide 5% gel
compared with the standard treatment with topical clindamycin1% lotion on the
frequency of active lesions in mild to moderate HS.
Study design
This study is a randomized, assessor blinded, prospective active controlled
intra-patient trial. Potentially eligible patients will be informed about the
study procedures and will be given ample time to consider their decision. After
obtaining informed consent patient will be screened for eligibility. Two
affected contralateral anatomical regions will be randomised to
clindamycin/benzoyl peroxide gel (Treatment A) of clindamycin 1% lotion
(Treatment B) and followed for 12 weeks, with an additional follow-up visit
after 4 weeks after end of treatment. Any other affected areas will be treated
with clindamycin lotion 1% according to the current guidelines.
Intervention
Twice daily application of topical clindamycin1%/benzoyl peroxide 5% gel.
Study burden and risks
Patients will visit the hospital every 4 weeks for a duration of 16 weeks. On
all visits patients will fill out a short questionnaire and physical
examination will be performed by a blinded physician. Moreover, patients will
be asked to complete a diary throughout the 16 weeks, to record active lesions.
Swabs will be taken from both randomized anatomical area*s at baseline, after
12 and 16 weeks to assess, microbiome diversity and the resistance patterns.
Swabs are safe and pose no risk to the patient Other risks for participating
patients are minimal and consist of the occurrence of treatment related side
effects and adverse events, including dryness, flaking and irritation of the
treated skin. Benefits for patients may include an improvement of HS symptoms;
a reduction of the frequency of active lesions.
dr. Molewaterplein 40
Rotterdam 3015 GD
NL
dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-004338-13-NL |
| CCMO | NL68260.078.18 |