Healthy VolunteersPhase 1NCT01594775
Oxytocin, Couple Interaction and Wound Healing
A Phase 1 study testing Syntocinon (Oxytocin) nasal spray in people with Healthy Volunteers, run by University of Zurich at 1 site in Switzerland.
Trial summary
effects of intranasal oxytocin and couple interaction on wound healing. Trial with medicinal product Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Syntocinon (Oxytocin) nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2011to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- healthy heterosexual couples
- in a stable relationship since > 1 year
Who cannot join
- breast feeding
- heavy smoking (> 5 cigarettes/d)
- extensive skin disease
- artificial UV irradiation during < 3 months before study inclusion
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Dept. of Dermatology
Zurich, 8091
About this study
effects of intranasal oxytocin and couple interaction on wound healing.
- Trial with medicinal product
- Conditions
- Healthy Volunteers
- Being tested
- Syntocinon (Oxytocin) nasal spray, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syntocinon (Oxytocin) nasal sprayDrug
two-times daily self-administration of nasal spray containing active substance (oxytocin) during five days after wounding.
PlaceboDrug
two-times daily self-administration of nasal spray containing placebo during five days after wounding.
| Study group | Role | What they receive |
|---|---|---|
| nasal spray | Active comparator | Not described Receives: Drug: Syntocinon (Oxytocin) nasal spray |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound size
wound healing process within seven days after wounding
Measured: seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startOct 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital ZuerichSeverin Laeuchli, MD, Principal investigator, University Hospital Zurich, Division of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594775
- Sponsor's protocol ID
- KEK-ZH-NR: 2009-0063
- Status last verified
- Feb 2014
- First submitted
- 7 May 2012
- Last updated
- 25 Feb 2014
- Results posted
- No
Publications
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. 2026 Feb 1;83(2):118-127. doi: 10.1001/jamapsychiatry.2025.3705.
PubMed 41222549Aguilar-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.
PubMed 40356464Doerr 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.
PubMed 35472193
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin, Couple Interaction and Wound Healing
- ClinicalTrials.gov ID
- NCT01594775
- Acronym / sponsor ID
- KEK-ZH-NR: 2009-0063
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 9 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
effects of intranasal oxytocin and couple interaction on wound healing.
- Trial with medicinal product
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nasal spray | Active comparator | Drug: Syntocinon (Oxytocin) nasal spray |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy heterosexual couples
- in a stable relationship since > 1 year
Key exclusion criteria (4 listed)
- breast feeding
- heavy smoking (> 5 cigarettes/d)
- extensive skin disease
- artificial UV irradiation during < 3 months before study inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Syntocinon (Oxytocin) nasal spraytwo-times daily self-administration of nasal spray containing active substance (oxytocin) during five days after wounding. | Drug | nasal spray |
| Placebotwo-times daily self-administration of nasal spray containing placebo during five days after wounding. | Drug | Placebo |
Primary outcome
wound size
Time frame: seven days
wound healing process within seven days after wounding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
- Derived from this study: PubMed 41222549Schneider 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. 2026 Feb 1;83(2):118-127. doi: 10.1001/jamapsychiatry.2025.3705.
- Derived from this study: PubMed 40356464Aguilar-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.
- Derived from this study: PubMed 35472193Doerr 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
Severin Laeuchli, MD principal investigator
University Hospital Zurich, Division of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Syntocinon (Oxytocin) nasal spray in people with Healthy Volunteers, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound size (time frame: seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01594775, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2014.