Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Edileia Bagatin, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01139749
First received: June 1, 2010
Last updated: October 9, 2011
Last verified: October 2011

June 1, 2010
October 9, 2011
October 2011
July 2012   (final data collection date for primary outcome measure)
  • Sebum secretion rate [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    Sebum secretion measure on forhead, along scalp line, using Sebumeter,Courage & Khazaka, Köln, Germany.
  • sebum secretion rate [ Time Frame: day 180 ] [ Designated as safety issue: No ]
    Sebum secretion measure on forhead, along scalp line, using Sebumeter, Courage & Khazaka, Köln, Germany
Same as current
Complete list of historical versions of study NCT01139749 on ClinicalTrials.gov Archive Site
  • Oral isotretinoin side effects [ Time Frame: day 0 ] [ Designated as safety issue: Yes ]
    Laboratorial tests for oral isotretinoin side effects evaluation: pregnancy test, blood counting, transaminases and lipide profile
  • oral isotretinoin side effects [ Time Frame: day 30 ] [ Designated as safety issue: Yes ]
    Laboratorial tests for oral isotretinoin side effects evaluation: pregnancy test, blood counting, transaminases and lipide profile
  • oral isotretinoin side effects [ Time Frame: day 180 ] [ Designated as safety issue: Yes ]
    Laboratorial tests for oral isotretinoin side effects evaluation: pregnancy test, blood counting, transaminases and lipide profile
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea
Clinical, Laboratorial and Quality of Life Trial to Evaluate the Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Seborrhea
  • Seborrheic Dermatitis
  • Quality of Life
  • 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
  • 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
  • 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
    Intervention: Drug: oral isotretinoin
  • Active Comparator: salicylic acid and ciclopirox olamine
    Subjects from comparison arm will be treated with topical salicylic acid and ciclopirox olamine shampoo
    Intervention: Drug: salicylic acid and ciclopirox olamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact: Edileia Bagatin, PhD 55-11-55497525 edileia_bagatin@yahoo.com.br
Contact: Cristhine SL Kamamoto, Ms 55-11-55497888 cristhineslk@yahoo.com.br
Brazil
 
NCT01139749
seb2010
Yes
Edileia Bagatin, Federal University of São Paulo
Federal University of São Paulo
Not Provided
Principal Investigator: Edileia Bagatin, PhD Federal University of São Paulo
Federal University of São Paulo
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP