Abstract
Objective
This study aimed to compare the effectiveness and safety of triphasic combined oral
contraceptives (OCs) containing ethinyl estradiol (EE) and norgestimate (NGM) and
biphasic combined OCs containing EE and desogestrel (DSG) in the treatment of mild
to moderate acne.
Study design
This was an investigator-blinded, randomized, parallel group trial conducted at 3
centers in Thailand. Female subjects 18–45 years old were assigned to one or the other
OCs and evaluated for efficacy and safety parameters at the baseline visit and after
1, 3 and 6 months of treatment.
Results
Among 201 randomized subjects, data from 93 subjects in the EE/NGM group and 95 subjects
in the EE/DSG group were analyzed. After 6 months of treatment with EE/NGM and EE/DSG,
no differences between formulations were found for the decrease in total acne lesion
counts (74.4% vs. 65.1%, respectively, p=.070) or facial improvement score. More women
using EE/NGM showed a decrease in severity of facial seborrhea than those using EE/DSG
(p=.005). No changes in weight were noted in either group as compared to baseline.
Conclusion
Multiphasic OCs containing EE/NGM and EE/DSG provided comparable efficacy and tolerability
in the treatment of acne. However, EE/NGM had a more beneficial effect on facial seborrhea
reduction than EE/DSG.
Implications
EE/NGM and EE/DSG are multiphasic OCs, which were shown to be clinically equally effective
for mild to moderate facial acne, and the multiphasic combined OC with NGM was more
effective for women with facial seborrhea. Clinicians may apply the results of this
study when considering treatment options for facial acne and seborrhea.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to ContraceptionAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- New treatments and therapeutic strategies for acne.Arch Fam Med. 2000; 9: 179-187
- An update on the pathogenesis and management of acne vulgaris.J Am Acad Dermatol. 2004; 51: S36-S38https://doi.org/10.1016/j.jaad.2004.01.023
- Effectiveness of oral contraceptives in the treatment of acne.Contraception. 1998; 58: 29S-33S
- Examining the use of oral contraceptives in the management of acne.Int J Womens Health. 2010; 2: 69-76
- Classification and pharmacology of progestins.Maturitas. 2008; 61: 171-180
- The phasic approach to oral contraception: the triphasic concept and its clinical application.Int J Fertil. 1983; 28: 121-140
- Comparative contraceptive efficacy and mechanism of action of the norgestimate-containing triphasic oral contraceptive.Acta Obstet Gynecol Scand Suppl. 1992; 71: 9-14
- Efficacy and safety of a monophasic and a triphasic oral contraceptive containing norgestimate.Am J Obstet Gynecol. 1994; 170: 1556-1561
- Progestational and androgenic receptor binding affinities and in vivo activities of norgestimate and other progestins.Contraception. 1990; 41: 399-410
- Norgestimate and ethinyl estradiol in the treatment of acne vulgaris: a randomized, placebo-controlled trial.Obstet Gynecol. 1997; 89: 615-622
- Effectiveness of norgestimate and ethinyl estradiol in treating moderate acne vulgaris.J Am Acad Dermatol. 1997; 37: 746-754
- Selectivity in progesterone and androgen receptor binding of progestagens used in oral contraceptives.Contraception. 1988; 38: 325-332
- Serum concentrations of ethinylestradiol, 3-keto-desogestrel, SHBG, CBG and gonadotropins during treatment with a biphasic oral contraceptive containing desogestrel.Horm Res. 1992; 38: 184-189
- Acne treatment with a new estroprogestinic biphasic combination containing desogestrel.Acta Eur Fertil. 1991; 22: 283-286
- The Leeds revised acne grading system.J Dermatol Treat. 1998; 9: 215-220
- Comparison of the effect on acne with a combiphasic desogestrel-containing oral contraceptive and a preparation containing cyproterone acetate.Eur J Contracept Reprod Health Care. 2001; 6: 46-53
- The effect of a phasic oral contraceptive containing desogestrel on seborrhea and acne.Eur J Contracept Reprod Health Care. 2006; 11: 6-13
- Effects of two estroprogestins containing ethynilestradiol 30 microg and drospirenone 3mg and ethynilestradiol 30 microg and chlormadinone 2mg on skin and hormonal hyperandrogenic manifestations.Gynecol Endocrinol. 2008; 24: 718-723
- Long-term efficacy and safety of a monophasic combined oral contraceptive containing 0.02mg ethinylestradiol and 2mg chlormadinone acetate administered in a 24/4-day regimen.Contraception. 2010; 81: 501-509
- Efficacy of an oral contraceptive containing EE 0.03mg and CMA 2mg (Belara®) in moderate acne resolution: a randomized, double-blind, placebo-controlled Phase III trial.Contraception. 2009; 80: 25-33
- Oral contraceptive discontinuation: a prospective evaluation of frequency and reasons.Am J Obstet Gynecol. 1998; 179: 577-582
Article info
Publication history
Published online: June 12, 2014
Accepted:
June 5,
2014
Received in revised form:
May 28,
2014
Received:
December 31,
2013
Footnotes
☆Source of funding and other support: This study was sponsored by Janssen-Cilag Thailand.
☆☆Disclosure statement: Osot Nerapusee is an employee of Janssen-Cilag and owns stock options at Johnson & Johnson. Other authors declared no conflicts of interest in conducting this study.
★ClinicalTrials.gov Identifier: NCT01466673.
Identification
Copyright
© 2014 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
