Acne VulgarisPhase 4NCT01466673

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

A Phase 4 study testing Ethinyl estradiol/Norgestimate (EE/NGM) and Ethinyl estradiol/Desogestrel (EE/DSG) in people with Acne Vulgaris, run by Janssen-Cilag Ltd.,Thailand at 3 sites in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Acne Vulgaris
What is being tested?: Ethinyl estradiol/Norgestimate (EE/NGM) and Ethinyl estradiol/Desogestrel (EE/DSG)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 201 participants
Where: 3 sitesThailand
Study dates: Dec 2008to Mar 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
No healthy volunteers
Adult

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

Trial locations and contacts

3 sites in 1 country.

Thailand3 sites

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

Other trials in Thailand

About this study

Official title: Comparative Study of the Effect on Acne With Norgestimate Containing Triphasic Oral Contraceptive and Biphasic Preparation Containing Desogestrel

Read the 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.

Conditions: Acne Vulgaris
Being tested: Ethinyl estradiol/Norgestimate (EE/NGM), Ethinyl estradiol/Desogestrel (EE/DSG)
Keywords: Acne Vulgaris, Ethinyl estradiol, Norgestimate, Desogestrel, Tricilest, Oilezz
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ethinyl estradiol/Norgestimate (EE/NGM)Drug
Also called Tricilest
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.
Ethinyl estradiol/Desogestrel (EE/DSG)Drug
Also called Oilezz
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.

Study groups in NCT01466673
Study group	Role	What they receive
Ethinyl estradiol/Norgestimate (EE/NGM)	Experimental	Not described Receives: Drug: Ethinyl estradiol/Norgestimate (EE/NGM)
Ethinyl estradiol/Desogestrel (EE/DSG)	Active comparator	Not described Receives: Drug: Ethinyl estradiol/Desogestrel (EE/DSG)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Month 1
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.
Measured: Baseline and Month 3
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.
Measured: Baseline and Month 6

Secondary outcomes (7)

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.
Measured: Month 1, 3 and 6
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.
Measured: Month 1, 3 and 6
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.
Measured: Baseline and Month 1, 3 and 6
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.
Measured: Month 6
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.
Measured: Month 6
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.
Measured: Baseline and Month 6
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.
Measured: Baseline and Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Mar 2010

First posted8 Nov 2011 (estimated)
Study startDec 2008
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 201 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01466673
Sponsor's protocol ID: CR015448
Other IDs: NRGMONCON4003
Status last verified: Jun 2013
First submitted: 24 Oct 2011
Last updated: 19 Jun 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 25074072

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Study of the Effect on Acne With Norgestimate Containing Triphasic Oral Contraceptive and Biphasic Preparation Containing Desogestrel
ClinicalTrials.gov ID: NCT01466673
Acronym / sponsor ID: CR015448
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris, Ethinyl estradiol, Norgestimate, Desogestrel, Tricilest, Oilezz
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 201 participants (actual)
Lead sponsor: Janssen-Cilag Ltd.,ThailandIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 8 Nov 2011 (estimated)
Results: Posted 19 Jun 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Ethinyl estradiol/Norgestimate (EE/NGM)	Experimental	Drug: Ethinyl estradiol/Norgestimate (EE/NGM)
Ethinyl estradiol/Desogestrel (EE/DSG)	Active comparator	Drug: Ethinyl estradiol/Desogestrel (EE/DSG)

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ethinyl estradiol/Norgestimate (EE/NGM)Also: TricilestEthinyl 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.	Drug	Ethinyl estradiol/Norgestimate (EE/NGM)
Ethinyl estradiol/Desogestrel (EE/DSG)Also: OilezzEthinyl 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.	Drug	Ethinyl estradiol/Desogestrel (EE/DSG)

Primary outcome

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.

7 secondary outcomes

Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6
Time frame: Month 1, 3 and 6
Number of Participants Non-Compliant With Therapy
Time frame: Month 1, 3 and 6
Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6
Time frame: Baseline and Month 1, 3 and 6
Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6
Time frame: Month 6
Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6
Time frame: Month 6
Change From Baseline in Blood Pressure (BP) at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Body Weight at Month 6
Time frame: Baseline and Month 6

Results and safety

Results posted to the registry on 19 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ethinyl Estradiol/Norgestimate (EE/NGM)	100	93
Ethinyl Estradiol/Desogestrel (EE/DSG)	101	95

Primary outcome: Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1

Time frame: Baseline and Month 1. Mean (Standard Deviation). Unit: Lesions

Measure	Ethinyl Estradiol/Norgestimate (EE/NGM) n = 100	Ethinyl Estradiol/Desogestrel (EE/DSG) n = 101
Comedones Counts: Baseline	10.97 (6.45)	11.43 (7.58)
Papules Counts: Baseline	4.32 (4.94)	4.46 (5.06)
Pustules Counts: Baseline	0.90 (1.96)	1.12 (2.26)
Nodules Counts: Baseline	0.12 (0.86)	0.00 (0.00)
Total Counts: Baseline	16.31 (9.57)	17.00 (10.41)
Comedones Counts: Change at Month 1	3.43 (4.82)	3.44 (5.31)
Papules Counts: Change at Month 1	0.20 (3.73)	0.62 (2.19)
Pustules Counts: Change at Month 1	0.35 (0.96)	0.18 (0.82)

Population analysed: Intent-to-treat population (ITT) included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.

Primary outcome: Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3

Time frame: Baseline and Month 3. Mean (Standard Deviation). Unit: Lesions

Measure	Ethinyl Estradiol/Norgestimate (EE/NGM) n = 100	Ethinyl Estradiol/Desogestrel (EE/DSG) n = 101
Comedones Counts: Change at Month 3 (n=93, 96)	5.71 (6.93)	5.60 (6.70)
Papules Counts: Change at Month 3 (n=93, 96)	2.83 (3.80)	1.89 (2.92)
Pustules Counts: Change at Month 3 (n=93, 96)	0.63 (1.58)	0.70 (1.50)
Nodules Counts: Change at Month 3 (n=93, 96)	0.12 (0.90)	0.00 (0.00)
Total Counts: Change at Month 3 (n=93, 96)	8.84 (8.13)	8.19 (7.78)

Population analysed: ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. "n" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.

Primary outcome: Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6

Time frame: Baseline and Month 6. Mean (Standard Deviation). Unit: Lesions

Measure	Ethinyl Estradiol/Norgestimate (EE/NGM) n = 100	Ethinyl Estradiol/Desogestrel (EE/DSG) n = 101
Comedones Counts: Change at Month 6 (n=93, 95)	9.02 (6.30)	8.21 (7.43)
Papules Counts: Change at Month 6 (n=93, 95)	3.52 (5.08)	2.77 (4.62)
Pustules Counts: Change at Month 6 (n=93, 95)	0.77 (2.17)	0.96 (2.12)
Nodules Counts: Change at Month 6 (n=93, 95)	0.13 (0.89)	0.00 (0.00)
Total Counts: Change at Month 6 (n=93, 95)	13.44 (9.74)	11.94 (10.08)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Month 6. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ethinyl Estradiol/Norgestimate (EE/NGM)	2 of 100 (2%)	34 of 100 (34%)	Not reported
Ethinyl Estradiol/Desogestrel (EE/DSG)	0 of 101 (0%)	60 of 101 (59.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25074072Jaisamrarn 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen-Cilag Ltd., Thailand Clinical Trial study director

Janssen-Cilag Ltd.,Thailand

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ethinyl estradiol/Norgestimate (EE/NGM) and Ethinyl estradiol/Desogestrel (EE/DSG) in people with Acne Vulgaris, run by Janssen-Cilag Ltd.,Thailand at 3 sites in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1 (time frame: Baseline and Month 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01466673, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2013.