Stress PhysiologyPhase 4NCT04127279
Stress Relief Properties of a Cosmetic Routine
A Phase 4 study testing Cream in people with Stress Physiology and Stress, Psychological, run by University of Parma at 1 site in Italy.
Trial summary
Everyday life psychosocial challenges may negatively impact health and well-being, contributing to the onset and/or progression of psychological and psychosomatic disorders. Pharmacological treatments can moderate our stress response, but they usually bring about addiction/tolerance and a number of other side effects. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Physiology, Stress, Psychological
- What is being tested?
- Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2018to 14 Dec 2018
- Phase
- Phase 4
- 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 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female gender
- 25 to 50 years old
Who cannot join
- current or past neurological, psychiatric, and cardiac disorders
- cognitive impairment
- substance or alcohol abuse or dependence
- recent (last 12 months) traumatic events such as a death in the family, serious accident, job firing or divorce
- caregiving (last 12 months) a family member with serious pathology or disability
- current psychotropic or contraceptive drug use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stress Relief Properties of a Cosmetic Routine: Psychobiological Evidence
Everyday life psychosocial challenges may negatively impact health and well-being, contributing to the onset and/or progression of psychological and psychosomatic disorders. Pharmacological treatments can moderate our stress response, but they usually bring about addiction/tolerance and a number of other side effects. Therefore, it is relevant to identify alternative stress relief strategies that are devoid of these unwanted drawbacks. Moreover, the effects of such alternative interventions should be objectively quantified by means of reliable psychobiological parameters. The goal of this study was to quantify the acute and persistent effects of a cosmetic routine based on the self-administration of a cream enriched with essential oils, namely Juniperus Phoenicea gum extract, Copaifera Officinalis resin, Aniba Rosodora wood oil, and Juniperus Virginiana. This aim was achieved by measuring the (re-)activity of the autonomic nervous system (via heart variability indexes) and the hypothalamic-pituitary-adrenocortical axis (via salivary cortisol levels), as well as through psychometric and behavioral assessments.
Participants' informed consent signature for adhesion at the study was initially requested. With their acceptance, parameters were recorded anonimously, identified by their initials and an alphanumeric code.
Data were transferred on Excel worksheets, utilized for descriptive analysis related at every variable. All statistical analyses were performed using SPSS 25 software package and statistical significance was set at p<0.05.
Read the detailed description
Everyday life psychosocial challenges may negatively impact health and well-being, contributing to the onset and/or progression of psychological and psychosomatic disorders. Pharmacological treatments can moderate our stress response, but they usually bring about addiction/tolerance and a number of other side effects. Therefore, it is relevant to identify alternative stress relief strategies that are devoid of these unwanted drawbacks. Moreover, the effects of such alternative interventions should be objectively quantified by means of reliable psychobiological parameters.
The goal of this study was to quantify the acute and persistent effects of a cosmetic routine based on the self-administration of a cream (DAVC) enriched with essential oils, namely Juniperus Phoenicea gum extract, Copaifera Officinalis resin, Aniba Rosodora wood oil, Juniperus Virginiana. This aim was achieved by measuring the (re-)activity of the autonomic nervous system (via heart variability indexes) and the hypothalamic-pituitary-adrenocortical axis (via salivary cortisol levels), as well as through psychometric and behavioral assessments.
Fourty women, 25-50 years old, were instructed for a correct mode of self administration of the cream. On day 0, women came to the lab and were instrumented for electrocardiographic signal (ECG) recordings. Initially, a 10-min ECG was collected in resting conditions (baseline). Then, two 20-min ECGs were recorded, each following the self-administration (3-min duration) of the DAVC and a placebo cream (PLAC), in a randomized order. At the end of the baseline and the two post-cream administration recordings, saliva samples were collected. From day 1 to 28, subjects self-administered (at home, twice a day, at wake-up and bed time) either DAVC (n=20) or PLAC (n=20).
On day 29, they returned to the lab and ECGs and underwent a stress test (Trier Social Stress Test, TSST). The test lasted 10 min and consisted in a stress interview (5 min), immediately followed by an arithmetic task. ECGs were collected in baseline (10 min), test (10 min), and recovery (20 min) phases. Saliva samples were collected at the end of the baseline and the middle and the end of the recovery phase. The subjects filled a number of psychological questionnaires, including Profile of Mood States (POMS, on day 0 and 29) and STAI-Y1 (on day 29). In addition, subjects were videorecorded during the TSST, in order to quantify their non verbal behavior patterns (via ECSI).
A single, self-administration of DAVC (day 0) produced a significant, acute potentiation of parasympathetic neural modulation (HF index: 25% increase as to baseline), whereas PLAC produced only a modest change (3% increase). DAVC provoked a modest (10%), non significant reduction of cortisol levels, which was similar to that induced by PLAC.
Prolonged DAVC self-administration (4 weeks) produced: (i) a significant inhibition of stress-induced cortisol elevation on day 29 (55% increase as compared to pre-stress value in DAVC group, 75% in PLAC group); (ii) a significant improvement of mood profile (POMS test) on day 29 compared to day 0; (iii) a reduction of perceived anxiety (STAI-Y1 score) at the end of the TSST; (iv) significantly lower scores of behavioral patterns linked to anxiety, motivational conflict and avoidance and higher scores of affiliation during the TSST, as compared to PLAC group.
These autonomic neural, neuroendocrine and psychological data suggest that a cream enriched with essential oils has both acute and long-term stress-reduction effects on human psychophysiology. Acute effects involve a potentiation of the parasympathetic component of autonomic neural regulation, which is usually associated with well-being, relaxation and resilience. The long-term effects point to a generalized stress-relief property, involving both the hormonal and psychological sides of stress adaptation.
- Conditions
- Stress Physiology, Stress, Psychological
- Being tested
- Cream
- Keywords
- autonomic nervous system, HPA axis, anxiety, non verbal behavior
- Medical subject headings
- Stress, Psychological, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreamBiological
The enriched cream is self-administered and contains a blend of 4 essential oils, namely Juniperus phoenicea gum extract, Copaifera officinalis resin, Aniba rosaeodora wood oil and Juniperus virginiana oil.
The placebo cream is devoid of the essential oils
| Study group | Role | What they receive |
|---|---|---|
| Enriched Cream | Experimental | The enriched cream is self-administered and contains a blend of 4 essential oils, namely Juniperus phoenicea gum extract, Copaifera officinalis resin, Aniba rosaeodora wood oil and Juniperus virginiana oil. Receives: Biological: Cream |
| Placebo Cream | Active comparator | Cream devoid of essential oils, self-administered Receives: Biological: Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute autonomic stress responsivity (heart rate, HR) to cream self-administration
Mean HR, measured as bpm (beats per minute)
Measured: ECG recorded just before (for 10 minutes) the self-administration of the enriched and placebo creams (day 0)
Acute autonomic stress responsivity (heart rate, HR) to cream self-administration
Mean HR, measured as bpm (beats per minute)
Measured: ECG recorded just after (for 20 minutes) the self-administration of the enriched and placebo creams (day 0)
Acute autonomic stress responsivity (HF, vagal input to the heart) to cream self-administration
High frequency component power (HF) of the RR interval spectrum (n.u.)
Measured: ECG recorded just before (for 10 minutes) the self-administration of the enriched and placebo creams (day 0)
Acute autonomic stress responsivity (HF, vagal input to the heart) to cream self-administration
High frequency component power (HF) of the RR interval spectrum (n.u.)
Measured: ECG recorded just after (for 20 minutes) the self-administration of the enriched and placebo creams (day 0)
Acute HPA axis stress responsivity to cream self-administration
Determined by means of salivary cortisol levels (pg/ml)
Measured: Samples obtained just before the self-administration of the enriched and placebo creams
Acute HPA axis stress responsivity to cream self-administration
Determined by means of salivary cortisol levels (pg/ml)
Measured: Samples obtained after (20 min) the self-administration of the enriched and placebo creams
Acute HPA axis stress responsivity to the psychosocial stress test
Determined by means of salivary cortisol levels
Measured: Samples obtained just before the psychosocial stress test
Acute HPA axis stress responsivity to the psychosocial stress test
Determined by means of salivary cortisol levels
Measured: Samples obtained after (10 minutes) the psychosocial stress test
Acute HPA axis stress responsivity to the psychosocial stress test
Determined by means of salivary cortisol levels
Measured: Samples obtained after (30 minutes) the psychosocial stress test
Secondary outcomes (5)
Perceived stress
Determined via the Perceived Stress Scale (PSS) questionnaire. It is a measure of the degree to which situations in one's life are appraised as stressful. Items are designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The 10 questions that compose this test are related to feelings and thoughts experienced during the last month. In each case, respondents are asked how often they felt a certain way.
For each question, they had to choose from the following alternatives:
0=never, 1=almost never, 2=sometimes, 3=fairly often, 4=very often.
The PSS score was determined by following these directions:
First, the scores for questions 4, 5, 7, and 8 were reversed.
On these 4 questions, the scores were changed like this:
0 = 4, 1 = 3, 2 = 2, 3 = 1, 4 = 0.
Then scores were added up for each item to get a total. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: Before (day -2) the 4-week time period (day 0 to 28) during which subjects self-administered twice daily (at wake up time and bed time) the cream
Perceived stress
Determined via the Perceived Stress Scale (PSS) questionnaire. It is a measure of the degree to which situations in one's life are appraised as stressful. Items are designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The 10 questions that compose this test are related to feelings and thoughts experienced during the last month. In each case, respondents are asked how often they felt a certain way.
For each question, they had to choose from the following alternatives:
0=never, 1=almost never, 2=sometimes, 3=fairly often, 4=very often.
The PSS score was determined by following these directions:
First, the scores for questions 4, 5, 7, and 8 were reversed.
On these 4 questions, the scores were changed like this:
0 = 4, 1 = 3, 2 = 2, 3 = 1, 4 = 0.
Then scores were added up for each item to get a total. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: After (day 29) the 4-week time period (day 0 to 28) during which subjects self-administered twice daily (at wake up time and bed time) the cream
Profile of mood states
Determined via the Profile of Mood States (POMS) questionnaire. It is a rating scale that measures 6 distinct mood states, namely tension-anxiety (TA), depression-dejection (DD), anger-hostility (AH), fatigue-inertia (FI), confusion-bewilderment (CB), and vigor-activity (VA). Subjects are asked to report the intensity of these six different dimensions of mood as they felt them during the last week. Subjects self report on each of these areas using a 5-point Likert scale (0=not at all, 1=a little, 2=moderately, 3=quite a lot, 4=extremely). An overall score of mood profile (POMS score) can be drawn by summing the scores obtained in each of the five "negative" factors and subtracting the single positive factor (VA).
Measured: Before (day -2) the 4-week time period (day 0 to 28) during which subjects self-administered twice daily (at wake up time and bed time) the cream
Profile of mood states
Determined via the Profile of Mood States (POMS) questionnaire. It is a rating scale that measures 6 distinct mood states, namely tension-anxiety (TA), depression-dejection (DD), anger-hostility (AH), fatigue-inertia (FI), confusion-bewilderment (CB), and vigor-activity (VA). Subjects are asked to report the intensity of these six different dimensions of mood as they felt them during the last week. Subjects self report on each of these areas using a 5-point Likert scale (0=not at all, 1=a little, 2=moderately, 3=quite a lot, 4=extremely). An overall score of mood profile (POMS score) can be drawn by summing the scores obtained in each of the five "negative" factors and subtracting the single positive factor (VA).
Measured: After (day 29) the 4-week time period (day 0 to 28) during which subjects self-administered twice daily (at wake up time and bed time) the cream
Behavioral coping style
Determined via the quantification of 37 different patterns of non-verbal behavior. The recording session (10-min psychosocial stress) was divided into successive 15-second sample intervals. The instant of time at the end of each sample interval, referred to as the "sample point", was identified by a beeper. On the instant of each sample point, the observer recorded whether or not the behavior pattern had occurred during the preceding sample interval. The score of each behavior for each subject was expressed as the proportion of all sample intervals during which that behavior occurred.
Measured: During the psychosocial stress test (PST, day 29)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start15 Jan 2018
- Primary completion28 Sep 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress PhysiologyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Giovanna Bignami, University of Parma
- Investigators
- Andrea Sgoifo, PhD, Principal investigator, University of ParmaLuca Carnevali, PhD, Principal investigator, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127279
- Sponsor's protocol ID
- 46700 18122017
- Status last verified
- Oct 2019
- First submitted
- 26 Sep 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Relief Properties of a Cosmetic Routine: Psychobiological Evidence
- ClinicalTrials.gov ID
- NCT04127279
- Acronym / sponsor ID
- 46700 18122017
- Conditions
- Stress Physiology, Stress, Psychological
- Keywords
- autonomic nervous system, HPA axis, anxiety, non verbal behavior
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 15 Oct 2019 (actual)
- 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.
Everyday life psychosocial challenges may negatively impact health and well-being, contributing to the onset and/or progression of psychological and psychosomatic disorders. Pharmacological treatments can moderate our stress response, but they usually bring about addiction/tolerance and a number of other side effects. Therefore, it is relevant to identify alternative stress relief strategies that are devoid of these unwanted drawbacks. Moreover, the effects of such alternative interventions should be objectively quantified by means of reliable psychobiological parameters. The goal of this study was to quantify the acute and persistent effects of a cosmetic routine based on the self-administration of a cream enriched with essential oils, namely Juniperus Phoenicea gum extract, Copaifera Officinalis resin, Aniba Rosodora wood oil, and Juniperus Virginiana. This aim was achieved by measuring the (re-)activity of the autonomic nervous system (via heart variability indexes) and the hypothalamic-pituitary-adrenocortical axis (via salivary cortisol levels), as well as through psychometric and behavioral assessments.
Participants' informed consent signature for adhesion at the study was initially requested. With their acceptance, parameters were recorded anonimously, identified by their initials and an alphanumeric code.
Data were transferred on Excel worksheets, utilized for descriptive analysis related at every variable. All statistical analyses were performed using SPSS 25 software package and statistical significance was set at p<0.05.
Detailed description
Everyday life psychosocial challenges may negatively impact health and well-being, contributing to the onset and/or progression of psychological and psychosomatic disorders. Pharmacological treatments can moderate our stress response, but they usually bring about addiction/tolerance and a number of other side effects. Therefore, it is relevant to identify alternative stress relief strategies that are devoid of these unwanted drawbacks. Moreover, the effects of such alternative interventions should be objectively quantified by means of reliable psychobiological parameters.
The goal of this study was to quantify the acute and persistent effects of a cosmetic routine based on the self-administration of a cream (DAVC) enriched with essential oils, namely Juniperus Phoenicea gum extract, Copaifera Officinalis resin, Aniba Rosodora wood oil, Juniperus Virginiana. This aim was achieved by measuring the (re-)activity of the autonomic nervous system (via heart variability indexes) and the hypothalamic-pituitary-adrenocortical axis (via salivary cortisol levels), as well as through psychometric and behavioral assessments.
Fourty women, 25-50 years old, were instructed for a correct mode of self administration of the cream. On day 0, women came to the lab and were instrumented for electrocardiographic signal (ECG) recordings. Initially, a 10-min ECG was collected in resting conditions (baseline). Then, two 20-min ECGs were recorded, each following the self-administration (3-min duration) of the DAVC and a placebo cream (PLAC), in a randomized order. At the end of the baseline and the two post-cream administration recordings, saliva samples were collected. From day 1 to 28, subjects self-administered (at home, twice a day, at wake-up and bed time) either DAVC (n=20) or PLAC (n=20).
On day 29, they returned to the lab and ECGs and underwent a stress test (Trier Social Stress Test, TSST). The test lasted 10 min and consisted in a stress interview (5 min), immediately followed by an arithmetic task. ECGs were collected in baseline (10 min), test (10 min), and recovery (20 min) phases. Saliva samples were collected at the end of the baseline and the middle and the end of the recovery phase. The subjects filled a number of psychological questionnaires, including Profile of Mood States (POMS, on day 0 and 29) and STAI-Y1 (on day 29). In addition, subjects were videorecorded during the TSST, in order to quantify their non verbal behavior patterns (via ECSI).
A single, self-administration of DAVC (day 0) produced a significant, acute potentiation of parasympathetic neural modulation (HF index: 25% increase as to baseline), whereas PLAC produced only a modest change (3% increase). DAVC provoked a modest (10%), non significant reduction of cortisol levels, which was similar to that induced by PLAC.
Prolonged DAVC self-administration (4 weeks) produced: (i) a significant inhibition of stress-induced cortisol elevation on day 29 (55% increase as compared to pre-stress value in DAVC group, 75% in PLAC group); (ii) a significant improvement of mood profile (POMS test) on day 29 compared to day 0; (iii) a reduction of perceived anxiety (STAI-Y1 score) at the end of the TSST; (iv) significantly lower scores of behavioral patterns linked to anxiety, motivational conflict and avoidance and higher scores of affiliation during the TSST, as compared to PLAC group.
These autonomic neural, neuroendocrine and psychological data suggest that a cream enriched with essential oils has both acute and long-term stress-reduction effects on human psychophysiology. Acute effects involve a potentiation of the parasympathetic component of autonomic neural regulation, which is usually associated with well-being, relaxation and resilience. The long-term effects point to a generalized stress-relief property, involving both the hormonal and psychological sides of stress adaptation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enriched Cream | Experimental | Biological: CreamThe enriched cream is self-administered and contains a blend of 4 essential oils, namely Juniperus phoenicea gum extract, Copaifera officinalis resin, Aniba rosaeodora wood oil and Juniperus virginiana oil. |
| Placebo Cream | Active comparator | Biological: CreamCream devoid of essential oils, self-administered |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- female gender
- 25 to 50 years old
Key exclusion criteria (6 listed)
- current or past neurological, psychiatric, and cardiac disorders
- cognitive impairment
- substance or alcohol abuse or dependence
- recent (last 12 months) traumatic events such as a death in the family, serious accident, job firing or divorce
- caregiving (last 12 months) a family member with serious pathology or disability
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 |
|---|---|---|
| CreamThe enriched cream is self-administered and contains a blend of 4 essential oils, namely Juniperus phoenicea gum extract, Copaifera officinalis resin, Aniba rosaeodora wood oil and Juniperus virginiana oil. The placebo cream is devoid of the essential oils | Biological | Enriched Cream, Placebo Cream |
Primary outcome
Acute autonomic stress responsivity (heart rate, HR) to cream self-administration
Time frame: ECG recorded just before (for 10 minutes) the self-administration of the enriched and placebo creams (day 0)
Mean HR, measured as bpm (beats per minute)
Acute autonomic stress responsivity (heart rate, HR) to cream self-administration
Time frame: ECG recorded just after (for 20 minutes) the self-administration of the enriched and placebo creams (day 0)
Mean HR, measured as bpm (beats per minute)
Acute autonomic stress responsivity (HF, vagal input to the heart) to cream self-administration
Time frame: ECG recorded just before (for 10 minutes) the self-administration of the enriched and placebo creams (day 0)
High frequency component power (HF) of the RR interval spectrum (n.u.)
Acute autonomic stress responsivity (HF, vagal input to the heart) to cream self-administration
Time frame: ECG recorded just after (for 20 minutes) the self-administration of the enriched and placebo creams (day 0)
High frequency component power (HF) of the RR interval spectrum (n.u.)
Acute HPA axis stress responsivity to cream self-administration
Time frame: Samples obtained just before the self-administration of the enriched and placebo creams
Determined by means of salivary cortisol levels (pg/ml)
Acute HPA axis stress responsivity to cream self-administration
Time frame: Samples obtained after (20 min) the self-administration of the enriched and placebo creams
Determined by means of salivary cortisol levels (pg/ml)
Acute HPA axis stress responsivity to the psychosocial stress test
Time frame: Samples obtained just before the psychosocial stress test
Determined by means of salivary cortisol levels
Acute HPA axis stress responsivity to the psychosocial stress test
Time frame: Samples obtained after (10 minutes) the psychosocial stress test
Determined by means of salivary cortisol levels
Acute HPA axis stress responsivity to the psychosocial stress test
Time frame: Samples obtained after (30 minutes) the psychosocial stress test
Determined by means of salivary cortisol levels
5 secondary outcomes
Perceived stress
Time frame: Before (day -2) the 4-week time period (day 0 to 28) during which subjects self-administered twice daily (at wake up time and bed time) the cream
Perceived stress
Time frame: After (day 29) the 4-week time period (day 0 to 28) during which subjects self-administered twice daily (at wake up time and bed time) the cream
Profile of mood states
Time frame: Before (day -2) the 4-week time period (day 0 to 28) during which subjects self-administered twice daily (at wake up time and bed time) the cream
Profile of mood states
Time frame: After (day 29) the 4-week time period (day 0 to 28) during which subjects self-administered twice daily (at wake up time and bed time) the cream
Behavioral coping style
Time frame: During the psychosocial stress test (PST, day 29)
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 15 Oct 2019.
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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.
Andrea Sgoifo, PhD principal investigator
University of Parma
Luca Carnevali, PhD principal investigator
University of Parma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cream in people with Stress Physiology and Stress, Psychological, run by University of Parma at 1 site in Italy.
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 6 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 15 Oct 2019. 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 Italy. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Acute autonomic stress responsivity (heart rate, HR) to cream self-administration (time frame: ECG recorded just before (for 10 minutes) the self-administration of the enriched and placebo creams (day 0)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.