NCT05614557

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

March 21, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

November 1, 2022

Last Update Submit

September 4, 2023

Conditions

Wound Healing

Outcome Measures

Primary Outcomes (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.

    21+-2 days maximum

Secondary Outcomes (2)

  • Time needed for the scab to fall off

    21+-2 days maximum

  • Volume of microscopic treatment zones (MTZs) and recovery time

    21+-2 days maximum

Study Arms (3)

Control

NO INTERVENTION

Formulation 1

EXPERIMENTAL
Device: Stratacel

Formulation 2

EXPERIMENTAL
Device: Stratamed

Interventions

StratacelDEVICE

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

Formulation 1
StratamedDEVICE

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

Formulation 2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux universitaires de Genève

Geneva, Switzerland

Location

Related Publications (7)

  • 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.

    PMID: 16392146BACKGROUND

  • 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.

    PMID: 23346665BACKGROUND

  • 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.

    PMID: 24267314BACKGROUND

  • 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.

    PMID: 33276114BACKGROUND

  • 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.

    PMID: 31520439BACKGROUND

  • 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.

    PMID: 39688344DERIVED

  • 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.

    PMID: 39245876DERIVED

Study Officials

  • Hans J. Laubauch, Dr. med.

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 14, 2022

Study Start

March 21, 2023

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)