We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

A Single-Centre Clinical Trial to Assess Steroid Induced Skin Atrophy on Healthy Skin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02355639
Recruitment Status : Completed
First Posted : February 4, 2015
Last Update Posted : May 3, 2017
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:
The purpose of this study is to assess steroid induced skin atrophy by sonography.

Condition or disease Intervention/treatment Phase
Skin and Connective Tissue Diseases Drug: Clobetasol propionate 0.05 % ointment Drug: Betamethasone dipropionate 0.064 % ointment Drug: Petrolatum ointment Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: A Single-Centre, Explorative, Randomised, Investigator-Blinded, Negative-Controlled, Phase I Clinical Trial With Intra-Individual Comparison of Treatments to Assess Steroid Induced Skin Atrophy on Healthy Skin
Study Start Date : January 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: Clobetasol propionate 0.05 % ointment
Active drug
Drug: Clobetasol propionate 0.05 % ointment
Experimental: Betamethasone dipropionate 0.064 % ointment
Active drug
Drug: Betamethasone dipropionate 0.064 % ointment
Placebo Comparator: Petrolatum ointment
Placebo drug
Drug: Petrolatum ointment

Primary Outcome Measures :
  1. Change in skin thickness from baseline to end of treatment [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Relation of clinical features (skin transparency and telangiectasia) to the steroid induced skin atrophy after end of treatment [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Healthy male volunteers, 25 to 40 years old inclusive.
  2. Healthy skin on volar arms with a hairless area sufficient for measurements

Exclusion Criteria:

  1. Clinical skin atrophy, telangiectasia or striae on volar arms.
  2. Presence of any skin condition or colouration that would interfere with test sites or the response or assessment.
  3. Fitzpatrick skin type IV - VI.
  4. History or current evidence of infection, eczema or other relevant skin disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355639

Layout table for location information
Charité - Universitaetsmedizin Berlin, Department of Dermatology and Allergy
Berlin, Germany, 10117
Sponsors and Collaborators
LEO Pharma
Layout table for additonal information
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02355639    
Other Study ID Numbers: EXP-1090
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Connective Tissue Diseases
Pathological Conditions, Anatomical
Betamethasone Valerate
Betamethasone benzoate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents