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Determining the possible association of skin irritation threshold and hypertrophic scar formation

Determining the possible association of skin irritation threshold and hypertrophic scar formation - Irritation threshold and hypertrophic scars

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43681
Enrollment
60
Registered
2013-11-27
Start date
2014-08-18
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

littekenhypertrofie van de huid Hypertrophic scar raised scar

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Reduction mammoplasty, at least 3 months post-operative 18 years of age or older Legally competent Patient group: scar hypertrophy in at least one of the scars Control group: all scars have remained normal (flat) during the entire post-operative period

Exclusion criteria

Exclusion criteria: Fitzpatrick photo skin type V Skin disease, skin lesions Immunological disorders Pregnancy/lactation or systemic immunosuppressive treatment during the first two years post-operatively or during the patch test

Design outcomes

Primary

MeasureTime frame
The primary study parameter is the IT as determined by visual irritation grading scale after SLS patch test.

Secondary

MeasureTime frame
The secondary study parameters are IL1a/IL1Ra ratios in the SC, TEWL, erythema as measured with DermaSpectrometer®, response of PBMC*s to stimulation with LPS, leukocyte numbers and cytokines in serum.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)