The Use of Sun Protection After Hamam (Turkish Bath)

NCT03151980 | Completed

• 1 other identifier: Herlev and Gentofte Hospital
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Skin erythema

  Baseline until 24 hours after sun exposure.

• Pain

  Baseline until 24 hours after sun exposure.

Study Arms (2)

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

Interventions

Hamam treated skin and sun exposure PROCEDURE

Hamam is a skin treatment (soaping and scrubbing).

Hamam treated skin and sun exposure

Untreated skin and sun exposure OTHER

Skin that will not receive Hamam.

Untreated skin and sun exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead

Study Sites (1)

Herlev and Gentofte Hospital

Herlev, 2730, Denmark

Location

Study Officials

• Jacob Rosenberg, Professor

  University of Copenhagen, Herlev Hospital

  STUDY CHAIR

• Stina Öberg, MD

  University of Copenhagen, Herlev Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 12, 2017
• Study Start: May 12, 2017
• Primary Completion: May 14, 2017
• Study Completion: May 14, 2017
• Last Updated: August 9, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)