AzTrials
AzTrials

Wound HealingSPASM11NCT05614557

Impact of Silicon-based Formulations on Wound Healing of Laser-induced Microscopic Skin Lesions

A study testing Stratacel and Stratamed in people with Wound Healing, run by Stratpharma AG at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Delayed wound healing is considered a health problem with devastating consequences for patients, healthcare systems, and societies. Over the past 20 years, many other groups, as well as ourselves, have evaluated various alternatives to improve wound healing. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Wound Healing
What is being tested?
Stratacel and Stratamed
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSwitzerland
Study dates
21 Mar 2023to 31 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult volunteers age ≥18 years to 50 years
  • Subjects must be willing and able to participate as required by the protocol.
  • Subjects must be willing and able to provide written informed consent.

Who cannot join

  • Evidence of any relevant skin or systemic disease (for example diabetes mellitus, cardiovascular disease, hypertension, chronic or acute skin disease) possibly affecting the wound healing of the test site.
  • Any skin alteration (for example tattoo or scar) on the test site.
  • Test sites with terminal hairs
  • Pregnancy or breastfeeding.
  • History of hypertrophic scars or keloid formation or a similar abnormal wound healing.
  • Intake of any drug which in the evaluation of the investigator may interfere with the interpretation of trial results or are known to cause clinically relevant interferences.
  • Body Mass Index (BMI) > 36 kg/m².
  • Have any other condition (including drug abuse, alcohol abuse, or psychiatric disorder) that, in the opinion of the investigator, precludes the patient from following and completing the protocol.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Hôpitaux universitaires de Genève

    Geneva

Other trials in Switzerland

About this study

Delayed wound healing is considered a health problem with devastating consequences for patients, healthcare systems, and societies. Over the past 20 years, many other groups, as well as ourselves, have evaluated various alternatives to improve wound healing. Despite this, the scientific evidence demonstrating the efficacy of recently developed treatments is often limited. Stratacel® and Stratamed® are two gels approved by Swissmedic and the FDA for use in improving wound healing. To this end, the efficacy of these formulations has been visually tested by a physician or by patients. Using the most advanced medical technologies (confocal microscopy and LCOCT), this study aims to investigate the effect of these formulations on the healing of human skin. For this research, a total of 20 volunteers will be included in this study. Volunteers will have up to 7 follow-up appointments over 21 days. Each appointment will last approximately 30 minutes and will be used to perform external measurements of skin healing. All volunteers will use the same formulations (Stratacel® and Stratamed®) with the only difference between volunteers being the anatomical area of application of the formulation. This will be determined by chance. The active participation of the participant is requested for the application of the formulations on the skin twice a day during the trial.

Conditions
Wound Healing
Being tested
Stratacel, Stratamed

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • StratacelDevice

    Silicone-based formulation registered as a European class IIa, TGA (Therapeutic Goods Administration) and FDA listed Class I medical device (wound dressing).

  • StratamedDevice

    Silicone-based formulation registered as a European class IIa, TGA (Therapeutic Goods Administration) and FDA listed Class I medical device (wound dressing).

Study groups in NCT05614557
Study groupRoleWhat they receive
ControlNo interventionNot described
Formulation 1ExperimentalNot described
Receives: Device: Stratacel
Formulation 2ExperimentalNot described
Receives: Device: Stratamed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measurement of erythema severity via erythema index with and without silicon-based formulations.

    Erythema severity is measured using the erythema index (EI). EI will be evaluated by a Mexameter by means of duplicate measurements per skin area in arbitrary units.

    Measured: 21+-2 days maximum

Secondary outcomes (2)

  1. Time needed for the scab to fall off

    Time needed for the scab to fall off will be evaluated through the study of photo documentation conducted thorough the experiment. To obtain the best possible image of the microscopic treatment zones, a DermLite DL4 dermatoscope will be used. The dermatoscope is a non-invasive device, frequently used in dermatology, which allows a better observation of the skin surface by magnifying it.

    Measured: 21+-2 days maximum

  2. Volume of microscopic treatment zones (MTZs) and recovery time

    Volume of the MTZs and time to recovery will be evaluated using confocal microscopy. Either by using RCM or LC-OCT (both non-invasive), a minimum of 3 MTZs per region will be evaluated. MTZs will also be evaluated following the classical protocol of biopsy fullowed by H\&E staining.

    Measured: 21+-2 days maximum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2022
  2. Study start21 Mar 2023
  3. Primary completion31 Aug 2023
  4. Study completion31 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05614557
Sponsor's protocol ID
HealLive
Other IDs
2022-D0083
Acronym
SPASM11
Status last verified
Sep 2023
First submitted
1 Nov 2022
Last updated
6 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Laubach HJ, Tannous Z, Anderson RR, Manstein D. Skin responses to fractional photothermolysis. Lasers Surg Med. 2006 Feb;38(2):142-9. doi: 10.1002/lsm.20254.

    PubMed 16392146

  • Sandhofer M, Schauer P. The safety, efficacy, and tolerability of a novel silicone gel dressing following dermatological surgery. Skinmed. 2012 Nov-Dec;10(6):S1-7.

    PubMed 23346665

  • Monk EC, Benedetto EA, Benedetto AV. Successful treatment of nonhealing scalp wounds using a silicone gel. Dermatol Surg. 2014 Jan;40(1):76-9. doi: 10.1111/dsu.12366. Epub 2013 Nov 25. No abstract available.

    PubMed 24267314

  • Abdlaty R, Hayward J, Farrell T, Fang Q. Skin erythema and pigmentation: a review of optical assessment techniques. Photodiagnosis Photodyn Ther. 2021 Mar;33:102127. doi: 10.1016/j.pdpdt.2020.102127. Epub 2020 Dec 1.

    PubMed 33276114

  • Garbarino F, Migliorati S, Farnetani F, De Pace B, Ciardo S, Manfredini M, Reggiani Bonetti L, Kaleci S, Chester J, Pellacani G. Nodular skin lesions: correlation of reflectance confocal microscopy and optical coherence tomography features. J Eur Acad Dermatol Venereol. 2020 Jan;34(1):101-111. doi: 10.1111/jdv.15953. Epub 2019 Oct 15.

    PubMed 31520439

  • Del Rio-Sancho S, Christen-Zaech S, Martinez DA, Punchera J, Guerrier S, Laubach HJ. Line-field confocal optical coherence tomography coupled with artificial intelligence algorithms as tool to investigate wound healing: A prospective, randomized, single-blinded pilot study. J Eur Acad Dermatol Venereol. 2025 Aug;39(8):1481-1488. doi: 10.1111/jdv.20478. Epub 2024 Dec 17.

    PubMed 39688344

  • Del Rio-Sancho S, Christen-Zaech S, Alvarez Martinez D, Punchera J, Merat R, Laubach HJ. Comparing Line-Field Confocal Optical Coherence Tomography and Reflectance Confocal Microscopy on the In Vivo Healing Process of Lesions Induced by Fractional Photothermolysis. Lasers Surg Med. 2025 Jan;57(1):121-129. doi: 10.1002/lsm.23841. Epub 2024 Sep 8.

    PubMed 39245876

Questions about this trial

What is this clinical trial studying?

A study testing Stratacel and Stratamed in people with Wound Healing, run by Stratpharma AG at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of erythema severity via erythema index with and without silicon-based formulations. (time frame: 21+-2 days maximum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05614557, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in