hypertrophic scars skin allergic reaction
Conditions
Interventions
None listed
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Healthy human female volunteers who are prior to undergoing reduction mammoplasties, are 18 years or older and legally competent.
Exclusion criteria
Exclusion criteria: * Fitzpatrick photo skin type IV or higher * Skin disease, e.g. psoriasis, pemphigus vulgaris etc. * Skin lesions, tattoos or substantial hair growth on the patch test site * Pregnancy or lactation during the patch test * Topical immunosuppressive treatment of the upper arm in the last 7 days before the patch test * Application of skin lotions or ointments on the upper arm in the last 6 weeks before the patch test * Abundant exposure of the upper arm to UVR during the patch test * Systemic antibiotic treatment in the last 2 weeks before the patch test * Systemic immunosuppressive treatment * Immunological disorders: infectious disease, immune deficiencies, auto-immune disorders * Alcohol or drug abuse * Smoking * ASA classification 3 or higher * Simultaneous participation in another clinical study that could interfere with the outcome of this study * Performing physical activities which cause heavy sweating, sauna, swimming or extreme showers or baths during the patch test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: Primary parameter: IT as determined by visual irritation grading scale after SLS patch test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters: response of PBMC*s to stimulation with LPS, and cytokines in serum. | — |
Countries
Netherlands
Outcome results
None listed