No Medical ConditionNCT03151980
The Use of Sun Protection After Hamam (Turkish Bath)
A study testing Hamam treated skin and sun exposure and Untreated skin and sun exposure in people with No Medical Condition, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial summary
Hamam is a common spa treatment. During a Hamam, some of the outermost layer of the skin is removed. The investigators believe that partly removing a protective skin layer might increase the risk of sun burn, especially for skin that has not been exposed to sun for a long time. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- No Medical Condition
- What is being tested?
- Hamam treated skin and sun exposure and Untreated skin and sun exposure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 12 May 2017to 14 May 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years
- Healthy volunteers
- Skin types 1,2,3- Fitzpatrick scale
- Provided informed consent
Who cannot join
- Regular medication for a condition/disease
- Active skin disease
- Sun exposure on the back within four weeks prior to the start of the study
- History of premalignant or malignant skin lesions
- Tattoo covering more than half of the back
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Sun Protection After Hamam (Turkish Bath): a Randomized, Controlled, Blinded Trial
Hamam is a common spa treatment. During a Hamam, some of the outermost layer of the skin is removed. The investigators believe that partly removing a protective skin layer might increase the risk of sun burn, especially for skin that has not been exposed to sun for a long time.
The aim with this study is to assess if Hamam-treated skin is more susceptible to sun burn compared with untreated skin.
- Conditions
- No Medical Condition
- Being tested
- Hamam treated skin and sun exposure, Untreated skin and sun exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hamam treated skin and sun exposureProcedure or surgery
Hamam is a skin treatment (soaping and scrubbing).
Untreated skin and sun exposureOther
Skin that will not receive Hamam.
| Study group | Role | What they receive |
|---|---|---|
| Hamam treated skin and sun exposure | Active comparator | Not described Receives: Procedure: Hamam treated skin and sun exposure |
| Untreated skin and sun exposure | Other | Not described Receives: Other: Untreated skin and sun exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin erythema
Change in skin erythema: comparison of Hamam treated skin with untreated skin. Photographs of the skin will be assessed by computer analysis.
Measured: Baseline until 24 hours after sun exposure.
Secondary outcomes (2)
Skin erythema
Measured by a visual scale.
Measured: Baseline until 24 hours after sun exposure.
Pain
Measured by a visual analogue scale.
Measured: Baseline until 24 hours after sun exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start12 May 2017
- Primary completion14 May 2017
- Study completion14 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Medical ConditionStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each participant will be randomized to receive Hamam on either the left or the right side of the back. The other side will be left untreated. Each individual will thereafter receive a sun exposure of both the Hamam-treated skin and the untreated skin.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stina Öberg, Herlev and Gentofte Hospital
- Investigators
- Jacob Rosenberg, Professor, Study chair, University of Copenhagen, Herlev HospitalStina Öberg, MD, Principal investigator, University of Copenhagen, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151980
- Sponsor's protocol ID
- Herlev and Gentofte Hospital
- Status last verified
- Aug 2017
- First submitted
- 11 May 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Sun Protection After Hamam (Turkish Bath): a Randomized, Controlled, Blinded Trial
- ClinicalTrials.gov ID
- NCT03151980
- Acronym / sponsor ID
- Herlev and Gentofte Hospital
- Conditions
- No Medical Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 12 May 2017 (actual)
- Primary completion
- 14 May 2017 (actual)
- Study completion
- 14 May 2017 (actual)
- First posted
- 12 May 2017 (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.
Hamam is a common spa treatment. During a Hamam, some of the outermost layer of the skin is removed. The investigators believe that partly removing a protective skin layer might increase the risk of sun burn, especially for skin that has not been exposed to sun for a long time.
The aim with this study is to assess if Hamam-treated skin is more susceptible to sun burn compared with untreated skin.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Each participant will be randomized to receive Hamam on either the left or the right side of the back. The other side will be left untreated. Each individual will thereafter receive a sun exposure of both the Hamam-treated skin and the untreated skin.
| Arm | Type | Receives |
|---|---|---|
| Hamam treated skin and sun exposure | Active comparator | Procedure: Hamam treated skin and sun exposure |
| Untreated skin and sun exposure | Other | Other: Untreated skin and sun exposure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years
- Healthy volunteers
- Skin types 1,2,3- Fitzpatrick scale
- Provided informed consent
Key exclusion criteria (5 listed)
- Regular medication for a condition/disease
- Active skin disease
- Sun exposure on the back within four weeks prior to the start of the study
- History of premalignant or malignant skin lesions
- Tattoo covering more than half of the back
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 |
|---|---|---|
| Hamam treated skin and sun exposureHamam is a skin treatment (soaping and scrubbing). | Procedure or surgery | Hamam treated skin and sun exposure |
| Untreated skin and sun exposureSkin that will not receive Hamam. | Other | Untreated skin and sun exposure |
Primary outcome
Skin erythema
Time frame: Baseline until 24 hours after sun exposure.
Change in skin erythema: comparison of Hamam treated skin with untreated skin. Photographs of the skin will be assessed by computer analysis.
2 secondary outcomes
Skin erythema
Time frame: Baseline until 24 hours after sun exposure.
Pain
Time frame: Baseline until 24 hours after sun exposure.
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 9 Aug 2017.
- Individual participant dataSharing planned: No
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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.
Jacob Rosenberg, Professor study chair
University of Copenhagen, Herlev Hospital
Stina Öberg, MD principal investigator
University of Copenhagen, Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hamam treated skin and sun exposure and Untreated skin and sun exposure in people with No Medical Condition, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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 4 inclusion and 5 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 9 Aug 2017. 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 Denmark. 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.
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?
Skin erythema (time frame: Baseline until 24 hours after sun exposure.). 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 9 Aug 2017.