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Retrospective, case-control follow-up study for post-inflammatory hyperpigmentation after UVB irradiation in the heat pain assessment

Retrospective, case-control follow-up study for post-inflammatory hyperpigmentation after UVB irradiation in the heat pain assessment - PIH after UVB irradiation for heat pain assessment

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45476
Enrollment
138
Registered
2017-04-26
Start date
2017-05-05
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Post-inflammatory hyperpigmentation

Interventions

Hyperpigmentation
Pain model

Sponsors

Centre for Human Drug Research
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Healthy male and female subjects, who participated in one of these studies CHDR0729, CHDR1311, CHDR1422, CHDR1425, CHDR1431 or CHDR1440. 2. Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion criteria

Exclusion criteria: 1. Legal incapacity or inability to understand or comply with the requirements of the study

Design outcomes

Primary

MeasureTime frame
Incidence of hyperpigmented lesions by * Clinical scoring * Multispectral imaging * UV photography * Cross-polarized photography Hyperpigmented lesion size and severity as determined by * Clinical assessment with caliper * Multispectral imaging * UV photography * Cross-polarized photography Changes in lesion size and severity of hyperpigmented lesions over time

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)