A Multicentric Randomized Double-Blind Phase 3 Trial Evaluating the Efficacy of an Adapted Antibiotherapy in Hurley Stage 2 Active Hidradenitis Suppurativa Patients versus Tetracycline Derivative (ABCESS2)

Conditions

Hurley stage 2 active Hidradenitis Suppurativa

Brief summary

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

Detailed description

Efficacy: Physician HS evaluation: Physician Global Assessment (PGA), modified Sartorius score, HS clinical Response (HiSCR), International Hidradenitis Suppurativa Severity Score (IHS4) at each visit, Efficacy: Normalization of the worst lesion microbiome at W12 compared to baseline at inclusion, Efficacy: Patient's HS evaluation: Pain (visual analogic scale, number of painful days per month); Dermatology Life Quality Index (DLQI), Efficacy: Number of pain killers and antibiotic treatments prescribed for flares (acute worsening of one or more HS lesions), number of surgical drainages, Efficacy : Time without flare of HS after remission, number of flares using a patient journal, Efficacy: Identification of prognosis markers of response to treatments, Safety: Description of adverse events related to treatments, Safety: Description of adverse events related to protocol procedures other than treatments, Safety: Emergence of extended spectrum betalactamase and carbapenemase producing enterobacteriaceae as well as vancomycin resistant enterococci in the gut microflora

Related papers

No related papers found yet.

Interventions

DRUGRIFADINE 300 mg

DRUGgélule

DRUGPL4 : capsule for oral use composed of microcrystalline cellulose

DRUGDBCaps size AA capsule

DRUGMOXIFLOXACINE SANDOZ 400 mg

DRUGcomprimé pelliculé

DRUGIZILOX 400 mg

DRUGPL2 : caspule for oral use composed of cornstarch

DRUGcolloidal anhydrous silica

DRUGcochineal carmine

DRUGdbcaps size aa elongated capsule

DRUGAvalox® 400 mg Filmtabletten

DRUGFLAGYL 250 mg

DRUGPL5 : capsule for oral use composed of microcrystalline cellulose

DRUGN2 capsule

DRUGDBCaps size A capsule

DRUGROCEPHINE 1 g/3

DRUG5 ml

DRUGpoudre et solvant pour solution injectable (IM)

DRUGTETRALYSAL 150 mg

DRUGPL1 : ROCEPHINE 1 g/3

DRUGPL3 : capsule for oral use composed of riboflavin

DRUGmicrocrystalline cellulose

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

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

Secondary

Measure	Time frame
Efficacy: Physician HS evaluation: Physician Global Assessment (PGA), modified Sartorius score, HS clinical Response (HiSCR), International Hidradenitis Suppurativa Severity Score (IHS4) at each visit, Efficacy: Normalization of the worst lesion microbiome at W12 compared to baseline at inclusion, Efficacy: Patient's HS evaluation: Pain (visual analogic scale, number of painful days per month); Dermatology Life Quality Index (DLQI), Efficacy: Number of pain killers and antibiotic treatments prescribed for flares (acute worsening of one or more HS lesions), number of surgical drainages, Efficacy : Time without flare of HS after remission, number of flares using a patient journal, Efficacy: Identification of prognosis markers of response to treatments, Safety: Description of adverse events related to treatments, Safety: Description of adverse events related to protocol procedures other than treatments, Safety: Emergence of extended spectrum betalactamase and carbapenemase producing enter	—

Measure

Time frame

Efficacy: Physician HS evaluation: Physician Global Assessment (PGA), modified Sartorius score, HS clinical Response (HiSCR), International Hidradenitis Suppurativa Severity Score (IHS4) at each visit, Efficacy: Normalization of the worst lesion microbiome at W12 compared to baseline at inclusion, Efficacy: Patient's HS evaluation: Pain (visual analogic scale, number of painful days per month); Dermatology Life Quality Index (DLQI), Efficacy: Number of pain killers and antibiotic treatments prescribed for flares (acute worsening of one or more HS lesions), number of surgical drainages, Efficacy : Time without flare of HS after remission, number of flares using a patient journal, Efficacy: Identification of prognosis markers of response to treatments, Safety: Description of adverse events related to treatments, Safety: Description of adverse events related to protocol procedures other than treatments, Safety: Emergence of extended spectrum betalactamase and carbapenemase producing enter

—

Countries

France

Outcome results

None listed