NCT06568224

Brief Summary

Background: Hidradenitis suppurativa (HS) is a chronic inflammatory relapsing disease involving the axillae, breast ,groin and anogenital regions. The therapies of the disease are diverse, including medication and surgery. However, responses to treatments are variable and relapse is common, with no single agent being consistently effective. Objective: To evaluate the efficacy and safety of oral mesalazine treatment for hidradenitis suppurativa . Methods: Investigators reported a series of cases of patients who received oral mesalazine(1g qid) for hidradenitis suppurativa in our institution between May 2020 and September 2023. A total of 27 patients, 22 in the mild to moderate group and 5 in the severe group, were included in this study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 23, 2024

Completed
Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

3.3 years

First QC Date

May 27, 2024

Last Update Submit

August 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Therapeutic Effect of Methalazine on 27 Cases of Suppurative Hidradenitis

    We registered the number of patients who achieved HiSCR(%).

    Three and a half years

Interventions

oral mesalazine 1g qid

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The symptoms of the patients were papules, nodules, cysts, sinuses, pustules, fistulas and scars in the armpits, groin, buttocks, etc., often accompanied by significant pain and tenderness.

You may qualify if:

  • Recurrent painful or suppurative lesions
  • Typical clinical manifestations: the distribution of apocrine sweat glands is deep in painful nodules, abscesses, sinuses, scars;

You may not qualify if:

  • Severe neurological and psychiatric diseases
  • Tumor diseases
  • Pregnant women in lactation period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Provincial People's Hospital

Nanjing, Nanjing, 210029, China

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland Diseases

Intervention Hierarchy (Ancestors)

meta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

May 27, 2024

First Posted

August 23, 2024

Study Start

May 1, 2020

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

September 3, 2024

Record last verified: 2024-08

Locations