Impact of Silicon-based Formulations on Wound Healing of Laser-induced Microscopic Skin Lesions (SPASM11)

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.

Study Overview

• Status: Completed
• Conditions: Wound Healing
• Intervention / Treatment: Device: Stratacel; Device: Stratamed

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland
    • Hôpitaux Universitaires de Genève

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. Any skin alteration (for example tattoo or scar) on the test site.
3. Test sites with terminal hairs
4. Pregnancy or breastfeeding.
5. History of hypertrophic scars or keloid formation or a similar abnormal wound healing.
6. 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.
7. Body Mass Index (BMI) > 36 kg/m².
8. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Formulation 1	Device: Stratacel; Silicone-based formulation registered as a European class IIa, TGA (Therapeutic Goods Administration) and FDA listed Class I medical device (wound dressing).
Experimental: Formulation 2	Device: Stratamed; Silicone-based formulation registered as a European class IIa, TGA (Therapeutic Goods Administration) and FDA listed Class I medical device (wound dressing).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	21+-2 days maximum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	21+-2 days maximum
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.	21+-2 days maximum

Collaborators and Investigators

• Sponsor: Stratpharma AG
• Collaborators: University Hospital, Geneva
• Investigators: Principal Investigator: Hans J. Laubauch, Dr. med., Hôpitaux Universitaires de Genève

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: HealLive; 2022-D0083 (Other Identifier: Swissethics)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No