NCT01594775

Brief Summary

effects of intranasal oxytocin and couple interaction on wound healing.

  • Trial with medicinal product

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

February 25, 2014

Status Verified

February 1, 2014

Enrollment Period

2 years

First QC Date

May 7, 2012

Last Update Submit

February 24, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • wound size

    wound healing process within seven days after wounding

    seven days

Study Arms (2)

nasal spray

ACTIVE COMPARATOR
Drug: Syntocinon (Oxytocin) nasal spray

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

two-times daily self-administration of nasal spray containing active substance (oxytocin) during five days after wounding.

nasal spray

two-times daily self-administration of nasal spray containing placebo during five days after wounding.

Placebo

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • healthy heterosexual couples
  • in a stable relationship since \> 1 year

You may not qualify if:

  • breast feeding
  • heavy smoking (\> 5 cigarettes/d)
  • extensive skin disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Dept. of Dermatology

Zurich, 8091, Switzerland

Location

Related Publications (3)

  • Schneider E, Hernandez C, Brock R, Eckstein M, Bodenmann G, Heinrichs M, Ehlert U, Lauchli S, Ditzen B. Intranasal Oxytocin and Physical Intimacy for Dermatological Wound Healing and Neuroendocrine Stress: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Nov 12:e253705. doi: 10.1001/jamapsychiatry.2025.3705. Online ahead of print.

  • Aguilar-Raab C, Stoffel M, Fischer M, Eckstein M, Bodenmann G, Heinrichs M, Ehlert U, Ditzen B. Minimal couple intervention to improve psychobiological stress resilience. Br J Health Psychol. 2025 May;30(2):e12799. doi: 10.1111/bjhp.12799.

  • Doerr JM, Klaus K, Troxel W, Nater UM, Bodenmann G, Heinrichs M, Ehlert U, Ditzen B. The Effect of Intranasal Oxytocin on the Association Between Couple Interaction and Sleep: A Placebo-Controlled Study. Psychosom Med. 2022 Jul-Aug 01;84(6):727-737. doi: 10.1097/PSY.0000000000001091. Epub 2022 Apr 27.

MeSH Terms

Interventions

OxytocinNasal Sprays

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsAerosolsColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR
  • Severin Laeuchli, MD

    University Hospital Zurich, Division of Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2012

First Posted

May 9, 2012

Study Start

October 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

February 25, 2014

Record last verified: 2014-02

Locations