The Use of Sun Protection After Hamam (Turkish Bath)

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.

Study Overview

• Status: Completed
• Conditions: No Medical Condition
• Intervention / Treatment: Procedure: Hamam treated skin and sun exposure; Other: Untreated skin and sun exposure

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Herlev and Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ≥18 years
• Healthy volunteers
• Skin types 1,2,3- Fitzpatrick scale
• Provided informed consent

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Hamam treated skin and sun exposure	Procedure: Hamam treated skin and sun exposure; Hamam is a skin treatment (soaping and scrubbing).
OTHER: Untreated skin and sun exposure	Other: Untreated skin and sun exposure; Skin that will not receive Hamam.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin erythema	Change in skin erythema: comparison of Hamam treated skin with untreated skin. Photographs of the skin will be assessed by computer analysis.	Baseline until 24 hours after sun exposure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin erythema	Measured by a visual scale.	Baseline until 24 hours after sun exposure.
Pain	Measured by a visual analogue scale.	Baseline until 24 hours after sun exposure.

Collaborators and Investigators

• Sponsor: Herlev and Gentofte Hospital
• Investigators: Principal Investigator: Stina Öberg, MD, University of Copenhagen, Herlev Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 12, 2017
• Primary Completion (ACTUAL): May 14, 2017
• Study Completion (ACTUAL): May 14, 2017

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (ACTUAL): May 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Herlev and Gentofte Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No