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Efficacy of an Adapted Antibiotherapy in Hurley Stage 2 Hidradenitis Suppurativa Patients

ConditionHidradenitis Suppurativa
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-59
SponsorInstitut Pasteur

About this trial

The study evaluates the efficacy of an adapted antibiotherapy in Hurley stage 2 active Hidradenitis Suppurativa patients versus tetracycline derivative

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults < 60 years old

Recurrent inflammation occurring more than 2 times in the past 6 months in the inverse regions of the body, presenting with nodules, sinus-tracts and/or scarring.

Signs: Involvement of axilla, genitofemoral area, perineum, gluteal area (and infra-mammary areafor women). Presence of nodules (inflamed or noninflamed), sinus tracts (inflamed or noninflamed), abscesses, scarring (atrophic, mesh-like, red, hypertrophic or linear)

Active HS with i) ≥ 1 year of evolution and ii) ≥ 4 flares during the previous year

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • ROCEPHIN, metronidazole, RIFADIN, IZILOX, placebo combination therapy

    Drug

    a 3-week course of ceftriaxone injection + oral metronidazole followed by a 3-week course of oral rifampicin + moxifloxacin +metronidazole followed by a 6-week course of oral rifampicin + moxifloxacin

  • Lymecyclin and corresponding placebos of the experimental arm

    Drug

    12-week course of oral lymecycline.

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: Experimental treatmentExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of patients reaching clinical remission at week 12, defined by an improvement of 90% of the IHS4 score from the baseline (IHS4 (1))

The clinical remission is defined as a 90% improvement of the International Hidradenitis Suppurativa Severity Score (IHS4) at week 12 compared to the baseline. The IHS4 score is a validated composite score developped to assess dynamically HS severity (1). It is calculated by adding the number of inflammatory nodules to the number of abscesses multiplied by 2 and to the number of draining tunnels multiplied by 4. A total score of 3 or less corresponds to mild severity HS, 4-10 to moderate severity HS and 11 or higher to severe disease.

Time frame
at week 12

Secondary outcomes

1

Change in Physician Global Assessment (PGA)

Physician assessment describe by differents severity : from Clear (no nodule) to Very severe (more than 5 abscesses or fistulas) Score evaluated at baseline / week 6 / week 12/ week 24/ week 52

Time frame
from baseline to week 52
2

Change in Modified Sartorius score

Score calculated by points from 0 (better) with differents parameters involved such as location / number / size / type of lesions Score evaluated at baseline / week 6 / week 12/ week 24/ week 52

Time frame
from baseline to week 52
3

Change in Hurley Score

Score described with 3 stages from I (less severity) to III (most severe) Score evaluated at baseline / week 6 / week 12/ week 24/ week 52

Time frame
from baseline to week 52
4

Change in Hidradenitis Suppurativa Severity Score (IHS4) score

Score calculated by points from \<3pts (Mild) to \> 11pts (Severe) by nb of nodules, nb of abscesses and nb of draining tunnels Score evaluated at baseline / week 6 / week 12/ week 24/ week 52

Time frame
from baseline to week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Pasteur

Lead sponsor

Centre Hospitalier Universitaire de Caen

Collaborator

Hôpital Necker-Enfants Malades

Collaborator

Ministry of Health, France

Collaborator

Assistance Publique Hopitaux De Marseille

Collaborator

Source ClinicalTrials.gov
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