Hidradenitis Suppurativa Wound Care

NCT04354012 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB00063673
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this case series is to monitor time and outcome of healing of wounds associated with HS using Endoform \[ovine forestomach\], Hydrofera Blue \[methylene blue and gentian violet\], and Hypafix tape. a combination methylene blue, gentian violet, and ovine forestomach wound care product.

Conditions

Hidradenitis Suppurativa (HS)

Outcome Measures

Primary Outcomes (1)

• Percent Change in Wound Size

  Asses the percent healing that occurs over 8 weeks of follow-up using Endoform and Hydrofera Blue products

  Measure from Baseline to week 8

Secondary Outcomes (4)

• Change in Pain Assessment Scores

  Change from baseline to week 1

• Change in Pain Assessment Scores

  Change from week1 to week 2

• Change in Pain Assessment Scores

  Change from week 2 to week 4

• Change in Pain Assessment Scores

  Change from week 4 to week 8

Study Arms (1)

Treatment

EXPERIMENTAL

methylene blue, gentian violet, and ovine forestomach wound dressings to HS lesions

Combination Product: methylene blue, gentian violet, and ovine forestomach wound dressings

Interventions

methylene blue, gentian violet, and ovine forestomach wound dressings COMBINATION_PRODUCT

Hydrofera Blue is an antibacterial foam dressing that contains methylene blue and gentian violet to manage wounds. This is a safe, non-cytotoxic product that can be worn for 7 days while not inhibiting growth factors. This products wicks bacteria into the foam and away from the wound surface using natural negative pressure through capillary flow. Endoform (ovine forestomach) is a natural dermal template used in all phases of wound healing. This product helps to stabilize, build, and organize tissue in acute and chronic wounds. Hypafix tape aids in stabilization of wound dressings. This productIt is easy to apply, skin friendly, and comfortable to use.

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with hidradenitis suppurativa with non-healing wounds or draining abscesses/nodules
• Individuals over 18 years of age

You may not qualify if:

• Individuals younger than 18 years of age
• Individuals without a diagnosis of HS

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences Dermatology

Winston-Salem, North Carolina, 27104, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Methylene Blue; Gentian Violet

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aniline Compounds; Amines

Results Point of Contact

• Title: Research Administrative Coordinator
• Organization: Wake Forest

irichard@wakehealth.edu

336-716-2903

Study Officials

• Rita O Pichardo, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Case series

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 21, 2020
• Study Start: February 4, 2021
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: October 22, 2025
• Results First Posted: October 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)