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

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ClinicalTrials.gov Identifier: NCT02355639
Recruitment Status : Completed
First Posted : February 4, 2015
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Description
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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

Study Design
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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
Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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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


Locations
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Germany
Charité - Universitaetsmedizin Berlin, Department of Dermatology and Allergy
Berlin, Germany, 10117
Sponsors and Collaborators
LEO Pharma
More Information
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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:
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Connective Tissue Diseases
Atrophy
Pathological Conditions, Anatomical
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Clobetasol
Petrolatum
Betamethasone sodium phosphate
 Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Emollients
Dermatologic Agents