search
Back to results

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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Ethinyl estradiol/Norgestimate (EE/NGM)
Ethinyl estradiol/Desogestrel (EE/DSG)
Sponsored by
Janssen-Cilag Ltd.,Thailand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne Vulgaris, Ethinyl estradiol, Norgestimate, Desogestrel, Tricilest, Oilezz

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers
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

Sites / Locations

  • Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University
  • Department of Obstetrics and Gynecology, Faculty of Medicine, Siriraj Hospital, Mahidol University
  • Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ethinyl estradiol/Norgestimate (EE/NGM)

Ethinyl estradiol/Desogestrel (EE/DSG)

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Total and Each Type of Acne Lesions Count at 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
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
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.

Secondary Outcome Measures

Number of Participants With Abnormal Vaginal Blood Loss at 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
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
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
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
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
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
Change from Baseline in body weight is the value at Month 6 minus value at Baseline.

Full Information

First Posted
October 24, 2011
Last Updated
June 14, 2013
Sponsor
Janssen-Cilag Ltd.,Thailand
search

1. Study Identification

Unique Protocol Identification Number
NCT01466673
Brief Title
An Efficacy and Safety Study Comparing Oral Contraceptive Containing Norgestimate or Desogestrel for Acne Treatment
Official Title
Comparative Study of the Effect on Acne With Norgestimate Containing Triphasic Oral Contraceptive and Biphasic Preparation Containing Desogestrel
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag Ltd.,Thailand

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne Vulgaris, Ethinyl estradiol, Norgestimate, Desogestrel, Tricilest, Oilezz

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ethinyl estradiol/Norgestimate (EE/NGM)
Arm Type
Experimental
Arm Title
Ethinyl estradiol/Desogestrel (EE/DSG)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ethinyl estradiol/Norgestimate (EE/NGM)
Other Intervention Name(s)
Tricilest
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ethinyl estradiol/Desogestrel (EE/DSG)
Other Intervention Name(s)
Oilezz
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1
Description
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.
Time Frame
Baseline and Month 1
Title
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3
Description
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.
Time Frame
Baseline and Month 3
Title
Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6
Description
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.
Time Frame
Baseline and Month 6
Secondary Outcome Measure Information:
Title
Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6
Description
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.
Time Frame
Month 1, 3 and 6
Title
Number of Participants Non-Compliant With Therapy
Description
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.
Time Frame
Month 1, 3 and 6
Title
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Description
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.
Time Frame
Baseline and Month 1, 3 and 6
Title
Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6
Description
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.
Time Frame
Month 6
Title
Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6
Description
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.
Time Frame
Month 6
Title
Change From Baseline in Blood Pressure (BP) at Month 6
Description
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.
Time Frame
Baseline and Month 6
Title
Change From Baseline in Body Weight at Month 6
Description
Change from Baseline in body weight is the value at Month 6 minus value at Baseline.
Time Frame
Baseline and Month 6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag Ltd., Thailand Clinical Trial
Organizational Affiliation
Janssen-Cilag Ltd.,Thailand
Official's Role
Study Director
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University
City
Bangkok
Country
Thailand
Facility Name
Department of Obstetrics and Gynecology, Faculty of Medicine, Siriraj Hospital, Mahidol University
City
Bangkok
Country
Thailand
Facility Name
Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University
City
Chiang Mai
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
25074072
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs