We, Willingsford, are recruiting volunteers with active HS lesions. The aim of the evaluation is to optimise the ease-of-use of Acapsil as first-line treatment of active Hidradenitis Suppurativa lesions without sinus tracts.
The overall purpose of the study is to determine how to optimally use Acapsil (micropore-particle-technology) as first-line treatment of active lesions in Hidradenitis Suppurativa (HS). Acapsil is an EU-approved treatment for wounds and lesions; it is approved for direct sale (OTC). The study will focus on the practical use of Acapsil in treating specific identified lesions without associated sinus-tract formation. The focus will be to determine how it is best applied on different areas and on choice of secondary dressings to minimise impact on daily living while still taking into consideration the requirements of Acapsil. The study will be divided into 3 stages, and participants will be needed for each stage. We are currently recruiting for the first stage.
Please read about the study below, and if you fulfil the inclusion criteria and are interested in participating, please send an e-mail with your name, country, a short description of your HS, including the location of your lesions, and a high resolution, in focus picture of your lesion to contact @ willingsford.com – please remember to remove the spaces! All information will be kept confidential.
- Confirmed diagnosis of HS
- Geographically located in the EU. Ability to read and write in English.
- Presence of active open lesions that allow the application of Acapsil into these. Lesions where sinus-tracts open into the lesion are excluded. Lesions that are opened manually can be included. Acapsil needs to touch the affected area to be effective. A small opening in skin covering an otherwise big lesion will not allow the proper application of Acapsil and will need to be opened manually to be included.
- Willingness to follow Instructions for Use and to provide feedback on the use of Acapsil and suitability of secondary dressings, educational materials etc. Providing daily feedback and pictures during the active treatment period, which is expected to be 3-4 days, regular follow-up until complete healing and infrequent periodic follow-up thereafter to determine long-term outcome.
- Allowing the use of pictures of your lesions and your feedback for medical, scientific, educational, and informative purposes regarding Acapsil and MPPT. It will not be possible to identify you from the pictures or your feedback.
Study Programme (Stage 1)
The aim is to optimise how Acapsil is used on newly formed active lesions in different locations of the body and choice of secondary dressings to minimise impact on daily activities. You will receive a pack with Acapsil and secondary dressings. We will instruct you how to use Acapsil and we will be in daily contact via e-mail to guide you. For this purpose, we will need to receive pictures daily and your feedback on the use of Acapsil.
The use of Acapsil involves: daily thorough washing with tap water (nothing else), dapping the area gently dry; applying Acapsil onto or into the lesions; covering the area with a lint-free 100% cotton dressing kept in place by a tubular dressing. The aim is to allow air to access the area as much as possible. This can additionally be facilitated by using loose clothing made of natural materials, e.g. 100% cotton – no synthetics can be used. It is expected that Acapsil will need to be applied once daily for 3-4 days and thereafter the lesion needs peace to heal. Until fully healed, only water can be used for cleaning the area and the lesion site must continue to be allowed access to air to “breathe”. NO antibacterial soaps or lotions can be used. We will explain and help as much as possible on a daily basis. Acapsil is very easy to use but different to other approaches.
Acapsil is a new approved treatment for wounds that removes wound infections and supports healing in wounds, ulcers and burns. In a comparative clinical study, it was able to remove infections 60% quicker than an antibiotic (gentamicin) and an antiseptic (iodine) across a wide range of wound types. It has also been able to advance the healing of ulcers caused by pyoderma gangrenosum, a condition often associated with HS. Standard wound care products are not effective in pyoderma gangrenosum.
Acapsil is based on micropore particle technology (MPPT) and it functions as a passive immunotherapy. It uses micro-capillary and evaporative forces to remove moisture from the wound surface. These actions also remove the toxins and enzymes, that bacteria and fungi secrete to inhibit the immune system, and they create holes in the surface of biofilm. MPPT therefore disrupts the weaponry of bacteria and fungi in the wound, whereby the control of the wound environment is returned to the immune system. The immune system can now remove the infection and it can control and support the processes of regeneration required to close the wound.
Acapsil is safe, it only contains natural ingredients and it has not been associated with allergies, pain, skin or wound irritation etc. It does not contain any antimicrobials, its effects will not be limited by resistance and it will not contribute to antimicrobial resistance. New research has shown that both antibiotics and antiseptics contribute strongly to the development of resistance in the individual user and it is therefore desirable to avoid the use of these products in wounds and lesions as much as possible.
You can see an article in the US medical journal, Wounds about the technology behind Acapsil: https://www.woundsresearch.com/article/sams-dodd.
In relation to HS, a woman from Sweden with HS contacted us and after trying Acapsil, she wrote us: “I apologize for my tardy reply! I managed to get an infection, became rather depressed and everything was at a standstill for a while. The good news is Acapsil worked wonders and I am currently not even wearing a gauze. Today I have enjoyed a three hour walk with my dog for the first time in months. It truly feels like a miracle. I am forever in your gratitude for making Acapsil available to me. I am convinced that, if made easily accessible, it will save lives!(..As well as the publicly financed healthcare-budget.) “
A few days later she wrote: “I told him (her dermatologist) about Acapsil and showed him pictures of the ulcers (before and after). I showed him the scaring I have from previous wounds compared to whats left of the ulcers where I have used Acapsil. Where I have used Acapsil the scaring (or soon to be scars) is flat against the surrounding skin, whereas the older scars are bulging/hypertrophic.”
It is unlikely that Acapsil will affect the underlying condition of HS, but it will be able to address the active lesions. Acapsil will advance their healing and lead to a reduction in exudate level, smell, pain and scarring. This should also reduce any risk of tract-formation as these are caused by microbial colonisation/infection, however, it is unlikely to be able to address existing tracts as these usually are too narrow to allow filling them with Acapsil. However, if the tracts were opened surgically, Acapsil can with benefit be used to assist the healing process.