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Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea

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ClinicalTrials.gov Identifier: NCT01139749
Recruitment Status : Unknown
Verified October 2011 by Edileia Bagatin, Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : June 9, 2010
Last Update Posted : October 12, 2011
Sponsor:
Information provided by (Responsible Party):
Edileia Bagatin, Federal University of São Paulo

Study Description
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Brief Summary:
Oral isotretinoin is the gold standard drug to treat moderate to severe acne. Other indications like seborrhea, seborrheic dermatitis have been suggested. There is risk of reversible mucocutaneous side effects, as well as alterations in lipid profile and transaminases. The major problem is teratogenicity which demands pregnancy control from treatment beginning to one month after treatment end. Seborrhea and seborrheic dermatitis are chronic conditions characterized by oily skin, hair and scalp, erythema, desquamation and negative impact on quality of life. This will be an interventional, therapeutic and quality of life randomized, comparative (parallel groups), blinded evaluation clinical trial, comprising 50 men and women, aged 18 to 40. Treatment with low-dose oral isotretinoin will be compared to topical anti-seborrheic products to evaluate the reduction of sebaceous secretion and colonization of affected areas by yeasts of Malassezia gender. Efficacy will be evaluated by clinical parameters, as well as by sebum secretion measure and application of quality of life questionnaires. Safety will be evaluated by skin hydration measure, side effects report and observation. For subjects using oral isotretinoin blood counting, transaminases, lipid profile and pregnancy test will be requested as selection criteria, on days 30 and 180. Data will be submitted to statistical analysis.

Condition or disease Intervention/treatment Phase
Seborrhea Seborrheic Dermatitis Quality of Life Drug: oral isotretinoin Drug: salicylic acid and ciclopirox olamine Phase 4

Detailed Description:

Oral isotretinoin is a retinoid that controls gene expression related to cellular proliferation, differentiation, with specific action over sebocytes, reducting sebaceous gland size and secretion rate. Its binding to specific retinoid nuclear receptors is weak. It is the gold standard drug to treat moderate to severe acne. Other indications have been suggested: seborrhea, seborrheic dermatitis, rosacea and non-melanoma skin cancer prevention. There are well known reversible side effects like the mucocutaneous - cheilitis, dryness of skin, nose and eyes and risk of alterations in lipid profile and transaminases. The major problem is teratogenicity which demands pregnancy control by two different methods, from treatment beginning to one month after treatment end.

Seborrhea and seborrheic dermatitis are chronic and correlated conditions characterized by oily skin, hair and scalp, erythema, desquamation and negative impact on quality of life. Seborrhea is a very common problem, affecting 30% of population. Seborrheic dermatitis affects 3 to 5% of world population, with no differences for gender and race. The etiopathogenic factors involved in these conditions are: individual susceptibility, elevated sebaceous secretion and irritant action of products from lipophilic yeasts of Malassezia gender. The treatment usually involves topical use of corticosteroids, salicylic acid, ketoconazole, ciclopirox olamine, pimecrolimus and tacrolimus. The dermatosis impact on quality of life has been more and more evaluated by generic and specific questionnaires. The most used generic questionnaires are:"Dermatology Life Quality Index or DLQI" and "Medical Outcomes Study 36-Item Short-Form Health Survey or SF-36". Recently a specific questionnaire for oily skin named "Oily Skin Self-Image Questionnaire or OSSIQ" was published. This will be an interventional, therapeutic and quality of life randomized, comparative (parallel groups), blinded evaluation clinical trial, comprising 50 men and women, aged 18 to 40. Treatment with low-dose oral isotretinoin (20 mg a day, every other day) will be compared to topical anti-seborrheic products to evaluate the reduction of sebaceous secretion and colonization of affected areas by saprophyte yeasts of Malassezia gender. Efficacy will be evaluated by clinical parameters, as well as by sebum measure and application of two quality of life questionnaires: SF-36 and OSSIQ (after translation and validation for Brazilian Portuguese). Safety will be evaluated by skin hydration measure, side effects report and observation. The devices Sebumeter and Corneometer, from Courage & Khazaka, Köln, Germain, will be used. For subjects using oral isotretinoin blood counting, transaminases, lipid profile and pregnancy test will be requested as selection criteria, on days 30 and 180. Results will be submitted to statistical analysis.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical, Laboratorial and Quality of Life Trial to Evaluate the Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea.
Study Start Date : October 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Oral isotretinoin
Subjects from treatment arm will be treated with low-dose oral isotretinoin - 20 mg a day, every other day, for six months
 Drug: oral isotretinoin
capsules of 20 mg a day, every other day, for six months
Other Names:
  • low-dose oral isotretinoin
  • off label use of oral isotretinoin
Active Comparator: salicylic acid and ciclopirox olamine
Subjects from comparison arm will be treated with topical salicylic acid and ciclopirox olamine shampoo
 Drug: salicylic acid and ciclopirox olamine
Topical salicylic acid and ciclopirox olamine shampoo for scalp and face cleansing, every other day, for six months
Other Names:
  • anti-seborrheic treatment
  • anti-dandruff treatment


Outcome Measures
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Primary Outcome Measures :
  1. Sebum secretion rate [ Time Frame: day 0 ]
    Sebum secretion measure on forhead, along scalp line, using Sebumeter,Courage & Khazaka, Köln, Germany.

  2. sebum secretion rate [ Time Frame: day 180 ]
    Sebum secretion measure on forhead, along scalp line, using Sebumeter, Courage & Khazaka, Köln, Germany


Secondary Outcome Measures :
  1. Oral isotretinoin side effects [ Time Frame: day 0 ]
    Laboratorial tests for oral isotretinoin side effects evaluation: pregnancy test, blood counting, transaminases and lipide profile

  2. oral isotretinoin side effects [ Time Frame: day 30 ]
    Laboratorial tests for oral isotretinoin side effects evaluation: pregnancy test, blood counting, transaminases and lipide profile

  3. oral isotretinoin side effects [ Time Frame: day 180 ]
    Laboratorial tests for oral isotretinoin side effects evaluation: pregnancy test, blood counting, transaminases and lipide profile


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • consent form signature
  • presence of seborrhea and / or seborrheic dermatitis on face and scalp
  • good health
  • no previous treatment with oral isotretinoin in the last 6 months
  • normal laboratorial tests: pregnancy test, blood counting, transaminases and lipide profile
  • concordance on use of two anticonceptional methods, during and until one month after the end of the study

Exclusion Criteria:

  • difficulty to follow study conditions
  • pregnancy risk
  • diabetes
  • collagen diseases
  • bone or muscles diseases
  • alcohol abuse
  • hypervitaminosis A
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): NCT01139749


Contacts
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Contact: Edileia Bagatin, PhD 55-11-55497525 edileia_bagatin@yahoo.com.br
Contact: Cristhine SL Kamamoto, Ms 55-11-55497888 cristhineslk@yahoo.com.br

Locations
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Brazil
Federal University of Sao Paulo - Dermatology Department - Cosmetic Dermatology Unit Recruiting
Sao Paulo, SP, Brazil, 04022-000
Contact: Edileia Bagatin, PhD    55-11-55497525    edileia_bagatin@yahoo.com.br   
Contact: Cristhine SL Kamamoto, Ms    55-11-55497888    cristhineslk@yahoo.com.br   
Principal Investigator: Edileia Bagatin, PhD         
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Principal Investigator: Edileia Bagatin, PhD Federal University of São Paulo
More Information
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Responsible Party: Edileia Bagatin, MD, PhD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01139749    
Other Study ID Numbers: seb2010
First Posted: June 9, 2010    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011
Keywords provided by Edileia Bagatin, Federal University of São Paulo:
oral isotretinoin
sebaceous secretion
seborrhea
 seborrheic dermatitis
quality of life
Malassezia
Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Seborrheic
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous
Salicylic Acid
Ciclopirox
Salicylates
Isotretinoin
Dermatologic Agents
Anti-Infective Agents
Antifungal Agents
 Keratolytic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action