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

This study has been completed.
Société de Dermatologie Française
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: June 30, 2011
Last updated: July 2, 2015
Last verified: February 2015
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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]
  • Dermis thickness evaluated by ultrasound [ Time Frame: days 1, 15, 29 ]
  • Mineral receptors and glucoreceptors expression ratio performed by immunohistochemistry [ Time Frame: day 29 ]

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
Active Comparator: Clobetasol + Placebo
0.05% clobetasol + inert excipient
Drug: Clobetasol + Placebo
One application 6 days a week during 4 weeks
Active Comparator: Placebo + Spironolactone
Inert excipient + 5% spironolactone
Drug: Placebo + Spironolactone
One application 6 days a week during 7 weeks
Placebo Comparator: Placebo + placebo
Inert excipient
Drug: Placebo + Placebo
One application 6 days a week during 7 weeks

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.


Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01407471

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


Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01407471     History of Changes
Other Study ID Numbers: P071011
Study First Received: June 30, 2011
Last Updated: July 2, 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:
wound healing
mineral corticoid receptor

Additional relevant MeSH terms:
Pathological Conditions, Anatomical
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Anti-Inflammatory Agents
Hormones processed this record on September 21, 2017