NL-OMON51239WithdrawnNot Applicable
Further determining the possible association of skin irritation threshold and hypertrophic scar formation - Irritation threshold and hypertrophic scars-part two
Amsterdam UMC0 sites62 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 62
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 64 (—)
Inclusion Criteria
- •Healthy human female volunteers who are prior to undergoing reduction
- •mammoplasties, are 18 years or older and legally competent.
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
- •* Alcohol or drug abuse
- •* 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
Investigators
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