Topical Steroids Alone or Associated With Methotrexate in Bullous Pemphigoid

NCT02313870 | Completed Phase 3

• 1 other identifier: 7850
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 1

Brief Summary

This controlled multi-center randomized clinical trial, with direct individual benefit, will compare efficacy and safety of two strategies in non-localized BP care: a combined regimen using initial superpotent topical steroids associated with methotrexate for 4 weeks followed by methotrexate alone for 8 months and superpotent topical steroids alone maintained 9 months (current standard of care). The expected result is an equivalence between the two compared strategies in terms of safety and efficacy, MTX monotherapy during the maintenance phase being easier to manage and therefore associated with better compliance than topical steroids with less cutaneous side effects and most cost-effective.

Conditions

Bullous Pemphigoid

Keywords

Bullous pemphigoid; superpotent topical steroids; methotrexate; safety

Outcome Measures

Primary Outcomes (1)

• actuarial survival

  The primary endpoint is the actuarial survival rate with or without recurrence at 9 months in the topical steroid + methotrexate group (Arm A) compared to exclusive topical steroid group (Arm B).

  9 months

Secondary Outcomes (5)

• Initial control rate of the disease

  9 months

• Safety: The frequency of serious and significant adverse events

  9 months

• Frequency of relapses

  9 months

• Relapse-free survival

  9 months

• Easiness of use

  9 months

Study Arms (2)

A

EXPERIMENTAL

Superpotent topical steroids/methotrexate

Drug: clobetasol propionate + Methotrexate

B

OTHER

Superpotent topical steroids (clobetasol propionate)

Drug: clobetasol propionate alone

Interventions

clobetasol propionate + Methotrexate DRUG

daily applications of topical clobetasol propionate at a dose of 10 to 30 g / day depending on the patient's weight and the initial number of new blisters per day, associated with methotrexate (MTX) received either orally or subcutaneously at a dose of 12.5 mg / week in patients weighing less than 60 kg and with creatinine clearance greater than 50 ml / min (planned dose reduction to 10 mg / week in patients less than 60 kg or with a creatinine clearance less than 50 ml / min) for four weeks followed by oral or subcutaneous methotrexate alone at the same dose during following 8 months

A

clobetasol propionate alone DRUG

daily applications of topical clobetasol propionate at a dose of 10 to 30 g / day depending on the patient's weight and the initial number of new blisters per day, up to 14 days after control of the disease followed by 1 application every 2 days at the same dose for 4 weeks then an application twice a week for 4 weeks then once application a week until the end of the 9th month of treatment

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 18 years old or more
• Patients affiliated to social security system,
• Patients: = no prior topical steroid or superpotent topical steroids for less than 16 days using the same or equivalent dosage as the one used in the study a different regimen and this regardless of the clinical resultsOR receiving potent or superpotent topical steroids for at least 16 days with a different regimen than that used during the trial AND not controlled by this treatment (appearance of at least 3 new blisters per day)
• written consent of the patient or, if not possible, certified by a third party,
• Serum albumin ≥ 25 g / L

You may not qualify if:

• Localized bullous pemphigoid (area \<400 cm2: 20 x 20 cm)
• Major blood cytopenia: Hb ≤ 10 g / dl and / or leukocytes ≤ 3000 / mm3 and / or platelets ≤ 100,000 / mm3
• Creatinine Clearance appreciated by the formula MDRD \<30 ml / min
• Serum albumin \<25 g / L
• pregnancy-associated Pemphigoid
• Linear IgA Dermatosis identified by DIF
• Pemphigoid with clinically dominant mucosal lesions
• Relapse of previously diagnosed pemphigoid and still receiving treatment or for whom treatment was stopped for less than six months
• Known allergy to topical steroids and / or methotrexate
• recent history of liver disease (within two years) regardless of its nature or presence of active liver disease (transaminases and / or alkaline phosphatase greater than twice the upper standard laboratory)
• Chronic alcoholism (declared consumption of more than 60 g alcohol / day or approximately 0.5 L / day of wine)
• patient receiving notoriously hepatotoxic drugs or that can interfere with metabolism or haematological toxicity of Methotrexate
• Peptic ulcer proven by endoscopy performed during the last 15 days
• Severe Active infection regardless of its nature
• Evolutive neoplasia whatever its nature except basal cell carcinoma

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital Of Montpellier

Montpellier, 34295, France

Location

Related Publications (1)

• Dereure O, Bernard P, Chosidow O, Ingen-Housz-Oro S, Machet L, Duvert-Lehembre S, Maillard H, Abasq C, Sassolas B, Acquitter M, Konstantinou MP, Chaby G, Caux F, Le Roux-Villet C, Prost C, Avenel-Audran M, Delaporte E, Jeudy G, Mahe A, Montaudie H, Picard-Dahan C, Quereux G, Richard MA, Bourgault-Villada I, Jullien D, Lepelletier C, Fichel F, Sanchez M, Rouanet J, Labeille B, Mahe E, Pham-Ledard A, Herman F, Picot MC, Joly P. Combined methotrexate and short-term superpotent topical corticosteroids compared with prolonged superpotent topical corticosteroids alone in bullous pemphigoid: a multicentre, noninferiority randomised clinical trial. Br J Dermatol. 2026 Mar 10:ljag094. doi: 10.1093/bjd/ljag094. Online ahead of print.

  PMID: 41807108 RESULT

MeSH Terms

Conditions

Pemphigoid, Bullous

Interventions

Clobetasol; Methotrexate

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Olivier Dereure, MD, PhD

  University of Montpellier France; French Society of Dermatology; french group for study of blistering diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 10, 2014
• Study Start: January 22, 2008
• Primary Completion: May 26, 2015
• Study Completion: December 31, 2015
• Last Updated: April 24, 2026

Record last verified: 2022-01

Locations

FR (1)