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

Wound Healing Clinical Trial

— SPASM11  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05614557
• Other study ID #: HealLive
• Secondary ID: 2022-D0083
• Status: Completed
• Phase: N/A
• Start date: March 21, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: September 2023
• Source: Stratpharma AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wound Healing
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Switzerland	Hôpitaux universitaires de Genève	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
Stratpharma AG	University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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