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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Ltd.,Thailand
ClinicalTrials.gov Identifier:
NCT01466673
First received: October 24, 2011
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

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).


Condition Intervention Phase
Acne Vulgaris
Drug: Ethinyl estradiol/Norgestimate (EE/NGM)
Drug: Ethinyl estradiol/Desogestrel (EE/DSG)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparative Study of the Effect on Acne With Norgestimate Containing Triphasic Oral Contraceptive and Biphasic Preparation Containing Desogestrel

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Ltd.,Thailand:

Primary Outcome Measures:
  • Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1 [ Time Frame: Baseline and Month 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 1, 3 and 6 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Change from Baseline in body weight is the value at Month 6 minus value at Baseline.


Enrollment: 201
Study Start Date: December 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ethinyl estradiol/Norgestimate (EE/NGM) 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
Active Comparator: Ethinyl estradiol/Desogestrel (EE/DSG) 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466673

Locations
Thailand
Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University
Bangkok, Thailand
Department of Obstetrics and Gynecology, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Thailand
Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University
Chiang Mai, Thailand
Sponsors and Collaborators
Janssen-Cilag Ltd.,Thailand
Investigators
Study Director: Janssen-Cilag Ltd., Thailand Clinical Trial Janssen-Cilag Ltd.,Thailand
  More Information

No publications provided

Responsible Party: Janssen-Cilag Ltd.,Thailand
ClinicalTrials.gov Identifier: NCT01466673     History of Changes
Other Study ID Numbers: CR015448, NRGMONCON4003
Study First Received: October 24, 2011
Results First Received: February 22, 2013
Last Updated: June 14, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by Janssen-Cilag Ltd.,Thailand:
Acne Vulgaris
Ethinyl estradiol
Norgestimate
Desogestrel
Tricilest
Oilezz

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases
Contraceptive Agents
Contraceptives, Oral
Desogestrel
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Moxifloxacin
Norgestimate
Norgestimate, ethinyl estradiol drug combination
Norgestrel
Polyestradiol phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Contraceptive Agents, Female
Contraceptives, Oral, Combined
Contraceptives, Oral, Synthetic
Enzyme Inhibitors
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 20, 2014