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

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

Tracking Information

• First Submitted Date: January 27, 2015
• First Posted Date: February 4, 2015
• Last Update Posted Date: May 3, 2017
• Study Start Date: January 2015
• Actual Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 30, 2015): Change in skin thickness from baseline to end of treatment [ Time Frame: 4 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: January 30, 2015): Relation of clinical features (skin transparency and telangiectasia) to the steroid induced skin atrophy after end of treatment [ Time Frame: 4 weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Single-Centre Clinical Trial to Assess Steroid Induced Skin Atrophy on Healthy Skin
• 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
• Brief Summary: The purpose of this study is to assess steroid induced skin atrophy by sonography.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Other
• Condition: Skin and Connective Tissue Diseases

Intervention

• Drug: Clobetasol propionate 0.05 % ointment
• Drug: Betamethasone dipropionate 0.064 % ointment
• Drug: Petrolatum ointment

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 30, 2015): 16
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 2015
• Actual Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 25 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT02355639
• Other Study ID Numbers: EXP-1090
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: LEO Pharma
• Original Responsible Party: Same as current
• Current Study Sponsor: LEO Pharma
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: LEO Pharma
• Verification Date: May 2017