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
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|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|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|
Experimental: Clobetasol propionate 0.05 % ointment
Drug: Clobetasol propionate 0.05 % ointment
Experimental: Betamethasone dipropionate 0.064 % ointment
Drug: Betamethasone dipropionate 0.064 % ointment
Placebo Comparator: Petrolatum ointment
Drug: Petrolatum ointment
- Change in skin thickness from baseline to end of treatment [ Time Frame: 4 weeks ]
- Relation of clinical features (skin transparency and telangiectasia) to the steroid induced skin atrophy after end of treatment [ Time Frame: 4 weeks ]
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|Ages Eligible for Study:||25 Years to 40 Years (Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||Yes|
- Healthy male volunteers, 25 to 40 years old inclusive.
- Healthy skin on volar arms with a hairless area sufficient for measurements
- Clinical skin atrophy, telangiectasia or striae on volar arms.
- Presence of any skin condition or colouration that would interfere with test sites or the response or assessment.
- Fitzpatrick skin type IV - VI.
- History or current evidence of infection, eczema or other relevant skin disease.
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
|Charité - Universitaetsmedizin Berlin, Department of Dermatology and Allergy|
|Berlin, Germany, 10117|
|Responsible Party:||LEO Pharma|
|Other Study ID Numbers:||
|First Posted:||February 4, 2015 Key Record Dates|
|Last Update Posted:||May 3, 2017|
|Last Verified:||May 2017|
Connective Tissue Diseases
Pathological Conditions, Anatomical
Betamethasone sodium phosphate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Respiratory System Agents