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A study on healthy volunteers to optically measure the body's response to vasoactive substances in the skin.

A non-randomized experimental study to optically study pharmacodynamic responses in the delivery of vasoactive substances to the skin through iontophoresis in healthy volunteers

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2018-004624-11-SE
Enrollment
105
Registered
2019-01-25
Start date
2019-03-13
Completion date
Unknown
Last updated
2019-04-30

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

Conditions

Healthy volunteers

Interventions

Trade Name: Miochol-E Product Name: Acetylkohlin Pharmaceutical Form: Intraocular instillation solution Pharmaceutical form of the placebo: Concentrate

Sponsors

Region Östergötland
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age between 18 and 45 years Generally healthy and without medication No skin disease or other skin conditions Voluntary participation in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 105 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: The person doesn’t understand the oral or written information. Ongoing medication of any form, except contraceptives. Known hypertension, skin disease, cardiovascular disease, ongoing pregnancy. Damaged skin, bruises, scar tissue or tattoos on the forearm skin Smoker (has smoked within 6 months or smoked more than 100 cigarettes). Snusing (has been snus within 6 months). The research person has used nicotine preparations (chewing gum, patches, etc.) within the last 6 months Blood pressure above 140/90. No coffee, tea, alcoholic beverages or hard physical activity on the day of the trial Not fasting 2 hours before the trial.

Design outcomes

Primary

MeasureTime frame
Main Objective: To study in vivo dose-responses of vasoactive drugs administred by iontoforesis.;Secondary Objective: Not applicable.;Primary end point(s): ED50, minimum value, maximum value and hill slope (from the dose-response curve); Timepoint(s) of evaluation of this end point: Is measured continuously, at one minute intervals, before, during and after the iontophores.

Secondary

MeasureTime frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: N/A

Countries

Sweden

Contacts

Public ContactJoakim Henricson

Region Östergötland

joakim.henricson@regionostergotland.se004672234 62 24

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026