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Interest of Topical Spironolactone's Administration to Prevent Corticoid-induced Epidermal Atrophy (SPIREPI)

This study has been completed.
Sponsor:
Collaborator:
Société de Dermatologie Française
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01407471
First received: June 30, 2011
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to determine whether spironolactone could significantly reduce cutaneous atrophy due to corticosteroids.


Condition Intervention Phase
Cutaneous Atrophy Due to Corticosteroids
Drug: Clobetasol + Spironolactone
Drug: Clobetasol + Placebo
Drug: Placebo + Spironolactone
Drug: Placebo + Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Interest of Topical Spironolactone's Administration to Prevent Corticoid-induced Epidermal Atrophy

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • histological measure of epidermal thickness [ Time Frame: day 29 ] [ Designated as safety issue: No ]
    biopsies will be performed in the center of the treated sites. Epidermal thickness will be measured from the basal lamina to the lower border of the stratum corneum. This will be determined by image analysis from the average of fields per skin section.


Secondary Outcome Measures:
  • delay of healing after skin biopsies performed on day 29 [ Time Frame: days 32, 36, 39, 43, 46, 50 ] [ Designated as safety issue: No ]
  • Dermis thickness evaluated by ultrasound [ Time Frame: days 1, 15, 29 ] [ Designated as safety issue: No ]
  • Mineral receptors and glucoreceptors expression ratio performed by immunohistochemistry [ Time Frame: day 29 ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: September 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clobetasol + Spironolactone
0.05% clobetasol and 5% spironolactone
Drug: Clobetasol + Spironolactone
One application 6 days a week during 4 weeks
Other Name: Clobetasol + Spironolactone
Active Comparator: Clobetasol + Placebo
0.05% clobetasol + inert excipient
Drug: Clobetasol + Placebo
One application 6 days a week during 4 weeks
Other Name: Clobetasol + Placebo
Active Comparator: Placebo + Spironolactone
Inert excipient + 5% spironolactone
Drug: Placebo + Spironolactone
One application 6 days a week during 7 weeks
Other Name: Placebo + Spironolactone
Placebo Comparator: Placebo + placebo
Inert excipient
Drug: Placebo + Placebo
One application 6 days a week during 7 weeks
Other Name: Placebo + Placebo

Detailed Description:

skin cutaneous atrophy due to corticosteroids limits the long-term use of highly potent topical glucocorticoids which are the treatment of choice for many inflammatory skin diseases. This atrophy results in fragile skin, delay of healing, purpura, irreversible striae, telangiectasia and secondary infections. Up to now, no treatments can prevent efficiently skin atrophy.

The mineralocorticoid receptor, belonging to the superfamily of nuclear receptors, is expressed in human epidermis but its actual function is unknown. Experimental results in animals obtained in INSERM unit U772 by Dr N FARMAN suggest that spironolactone which is a mineralocorticoid receptor antagonist 1- might limit epidermal atrophy and 2- might promote healing.

Study description We propose to test clinically these hypotheses for the first time on humans, at the CIC in BICHAT's hospital on healthy volunteers: 1- by applying on the skin a highly potent cutaneous corticosteroids in association or not with spironolactone, 2- by applying or not spironolactone on wounds after 3-mm punch biopsies.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers of both sex, aged between 20 and 50 years
  • Woman with effective contraception and pregnancy test negative before inclusion.
  • Subject considered healthy after a detailed review (interview, clinical examination)
  • Subject belonging to a social security scheme (beneficiary or have the right)
  • Subject having signed a free and informed consent
  • Integrity of the skin at forearms
  • Subject available the next 7 weeks and able to go to CIC once a day from Monday to Friday
  • Subject accepting four skin biopsies at D29
  • no washing forearms during 2 hours after applications

Exclusion Criteria:

  • Chronic Alcoholism
  • Drug-addiction (comprehensive interview with a sampling in case of doubt)
  • Woman pregnant or breast-feeding
  • Subject involved in another trial or in exclusion period of another protocol
  • Subject has already received more than 3700 Euros in compensation for damages suffered constraints in the past 12 months for his involvement in biomedical researches
  • Subject has already participated in this protocol
  • Phototypes 5 and 6
  • Clinical skin atrophy
  • History of severe chronic skin disease
  • Problems of healing
  • Treatment with oral corticosteroids, mineralocorticoids or spironolactone (Aldactone, Flumach, Practon, Spiroctan, Spironone, Aldactazine, ALDALIX, Practazin, Spiroctazine ...)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407471

Locations
France
Bichat Hospital
Paris, France, 75877
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Société de Dermatologie Française
Investigators
Principal Investigator: Eve MAUBEC, MD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01407471     History of Changes
Other Study ID Numbers: P071011
Study First Received: June 30, 2011
Last Updated: August 25, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
aldosterone
clobetasol
atrophy
skin
epidermis
wound healing
mineral corticoid receptor
spironolactone

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical
Clobetasol
Spironolactone
Anti-Inflammatory Agents
Cardiovascular Agents
Diuretics
Diuretics, Potassium Sparing
Glucocorticoids
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014