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An Efficacy and Safety Study Comparing Oral Contraceptive Containing Norgestimate or Desogestrel for Acne Treatment

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ClinicalTrials.gov Identifier: NCT01466673
Recruitment Status : Completed
First Posted : November 8, 2011
Results First Posted : June 19, 2013
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Ltd.,Thailand

Tracking Information
First Submitted Date  ICMJE October 24, 2011
First Posted Date  ICMJE November 8, 2011
Results First Submitted Date  ICMJE February 22, 2013
Results First Posted Date  ICMJE June 19, 2013
Last Update Posted Date June 19, 2013
Study Start Date  ICMJE December 2008
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2013)
  • Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1 [ Time Frame: Baseline and Month 1 ]
    Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 1. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.
  • Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3 [ Time Frame: Baseline and Month 3 ]
    Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 3. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.
  • Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6 [ Time Frame: Baseline and Month 6 ]
    Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 6. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2011)
The change from baseline in total number of lesions at 6 months [ Time Frame: Baseline, 6 months ]
Number of lesions encompasses number of comedone (open or closed), papules, pustules, and nodules
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2013)
  • Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6 [ Time Frame: Month 1, 3 and 6 ]
    Vaginal blood loss encompasses spotting and bleeding. Spotting is defined as a bleeding requiring no or at most one sanitary pad per day; however, bleeding requires two or more sanitary pads per day.
  • Number of Participants Non-Compliant With Therapy [ Time Frame: Month 1, 3 and 6 ]
    Compliance was assessed by transforming the data of forgotten tablets listed in the diary cards. Number of participants who forgot to take the drug was reported.
  • Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6 [ Time Frame: Baseline and Month 1, 3 and 6 ]
    Sebum assessment that is facial seborrhea (very oily skin) was assessed using sebutape strip on the forehead. Percentage of participants with facial seborrhea were assessed using categorical scores ranging from level 1 (lowest) to level 5 (highest). Highest level indicates worsening.
  • Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6 [ Time Frame: Month 6 ]
    Percentage of participants showing treatment response on the Investigator's global assessment was graded on a 5-point scale as 0=worse, 1=no change, 2=fair, 3=good, and 4=excellent.
  • Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6 [ Time Frame: Month 6 ]
    Participant's self-assessment at end-of-therapy was measured by using the self-assessment questionnaire which included 3 questions, about the rating of acne improvement since start of study; comparison of this acne treatment with the one used in past and the continuity of treatment on physician's prescription to evaluate efficacy and acceptability of the study medication. The score was graded at 4 parameters as excellent, better, no change and worse.
  • Change From Baseline in Blood Pressure (BP) at Month 6 [ Time Frame: Baseline and Month 6 ]
    Blood pressure is the pressure of blood flowing through blood vessels. Change from Baseline in blood pressure is the value at Month 6 minus value at Baseline.
  • Change From Baseline in Body Weight at Month 6 [ Time Frame: Baseline and Month 6 ]
    Change from Baseline in body weight is the value at Month 6 minus value at Baseline.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2011)
  • The change from baseline in facial seborrhea at month 6 [ Time Frame: Baseline, 6 months ]
    Facial seborrhea was assessed by using Sebutape strip on the forehead. The strip was compared with reference patterns into 5 levels from 1 (lowest) to 5 (highest)
  • Percentage of subjects showing improvement on the investigator's global assessment [ Time Frame: At month 6 ]
    Percentage of subjects showing improvement on the investigator's global assessment was graded as excellent, good, fair, no change, and worse
  • Subject's end-of-therapy self assessment [ Time Frame: At month 6 ]
    Subject's end-of-therapy self assessment was measured by using the self-assessment questionnaire. The score was graded as much improved, somewhat improved, not improved, worse, and much worse.
  • Number of subjects with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1-6 months ]
  • The change from baseline in blood pressure at month 6 [ Time Frame: Baseline, 6 months ]
  • The change from baseline in body weight at month 6 [ Time Frame: Baseline, 6 months ]
  • The change from baseline in total vaginal blood loss at month 6 [ Time Frame: Baseline, 6 months ]
    Vaginal blood loss encompasses spotting and bleeding. Spotting is defined as a bleeding requiring no or at most one sanitary pad per day; however, bleeding requires two or more sanitary pads per day.
  • Compliance after treatments [ Time Frame: 1 Month, 3 Months, 6 Months ]
    Compliance is assessed by transforming the data of forgotten tablets listed in the diary cards
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy and Safety Study Comparing Oral Contraceptive Containing Norgestimate or Desogestrel for Acne Treatment
Official Title  ICMJE Comparative Study of the Effect on Acne With Norgestimate Containing Triphasic Oral Contraceptive and Biphasic Preparation Containing Desogestrel
Brief Summary The purpose of this study is to evaluate the efficacy and safety of Ethinyl estradiol and Norgestimate (EE/NGM) compared to Ethinyl estradiol and Desogestrel (EE/DSG), for treatment of female participants with mild to moderate acne vulgaris (pimples).
Detailed Description This is a single-blind (physician does not know the name of the assigned drug) and randomized (study drug assigned by chance) study to compare the effectiveness and safety of EE/NGM and EE/DSG in female participants using oral contraceptive and have mild to moderate acne vulgaris. Tablets of EE/NGM and EE/DSG will be administered orally once daily for 6 months and will be instructed to visit for evaluation at Month 1, 3 and 6 post-administration. The efficacy will be evaluated efficacy primarily through total acne lesions count, which will be recorded at these evaluation visits. Unused study medications will be collected and drug accountability will be documented. Participants' safety will be monitored throughout the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Ethinyl estradiol/Norgestimate (EE/NGM)
    Ethinyl estradiol/Norgestimate encapsulated oral tablet will be administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
    Other Name: Tricilest
  • Drug: Ethinyl estradiol/Desogestrel (EE/DSG)
    Ethinyl estradiol/Desogestrel oral formulation will be administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
    Other Name: Oilezz
Study Arms  ICMJE
  • Experimental: Ethinyl estradiol/Norgestimate (EE/NGM)
    Intervention: Drug: Ethinyl estradiol/Norgestimate (EE/NGM)
  • Active Comparator: Ethinyl estradiol/Desogestrel (EE/DSG)
    Intervention: Drug: Ethinyl estradiol/Desogestrel (EE/DSG)
Publications * Jaisamrarn U, Chaovisitsaree S, Angsuwathana S, Nerapusee O. A comparison of multiphasic oral contraceptives containing norgestimate or desogestrel in acne treatment: a randomized trial. Contraception. 2014 Nov;90(5):535-41. doi: 10.1016/j.contraception.2014.06.002. Epub 2014 Jun 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2013)
201
Original Actual Enrollment  ICMJE
 (submitted: November 3, 2011)
202
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Inclusion Criteria: - Needs contraception in the family planning - Mild to moderate acne vulgaris - Agrees to take only the supplied study drug as treatment for acne during the 6-month treatment phase of the study - Signs and dates an informed consent to participate in the study - female participants aged 18 to 45 years Exclusion Criteria: - Pregnant or nursing - Known hypersensitivity to any of the ingredients and currently having significant adverse experiences from ethinyl estradiol, norgestimate or desogestrel - Any coexisting medical condition or were taking any concomitant medication that is likely to interfere with safe administration of ethinyl estradiol/norgestimate and ethinyl estradiol/desogestrel, in the Investigator's opinion - Taking system retinoids, systemic antimicrobials, and topical acne treatments within 6 months, 1 month, and 2 weeks prior to enrollment, respectively - Taking investigational medication or oral contraceptives within 30 days prior to Screening
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01466673
Other Study ID Numbers  ICMJE CR015448
NRGMONCON4003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen-Cilag Ltd.,Thailand
Study Sponsor  ICMJE Janssen-Cilag Ltd.,Thailand
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen-Cilag Ltd., Thailand Clinical Trial Janssen-Cilag Ltd.,Thailand
PRS Account Janssen-Cilag Ltd.,Thailand
Verification Date June 2013

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