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Novial® effectively reduces seborrhea and acne after four cycles of treatment - contraception-esc.com

Novial® effectively reduces seborrhea and acne after four cycles of treatment

Novial® effectively reduces seborrhea and acne after four cycles of

treatment

H.T. Kränzlin (1), M.A. Nap (2)

Gynecology Private Practice, Munich, Germany (1); NV Organon, Oss, The

Netherlands (2)

Objective: Seborrhea is a pre-condition to acne, characterized by oily

skin and greasy hair. The objective of the study was to investigate the effect

of an oral contraceptive (Novial®) on facial seborrhea and acne compared with

no hormonal treatment.

Design and methods: In this open-label, non-randomized,

group-comparative multi-center trial,young women aged 18–30 with moderate to

severe seborrhea were enrolled after a 2-month washout phase. Women either used

Novial®, a phasic oral contraceptive containing ethinylestradiol (35/30/30 µg)

and desogestrel (50/100/150 µg) (n=177) or no hormonal treatment (control group;

n=77) for four cycles. Condoms were provided to the control group for

contraception. SebuTape®, an adhesive tape that absorbs facial oil when

attached to the skin, was used to measure seborrhea on the forehead and cheeks.

Computerized image analyses of the tapes were used to assess the number of

active follicles and the amount of excreted sebum. Qualitative tape assessments

were also performed. Acne was assessed by lesion counts, and questionnaires were

used to assess the subjects’ and physicians’ perception of skin condition.

Pregnancies and adverse events (AE) were recorded. Assessments were performed at

baseline, after two and four cycles/months, or at early discontinuation.

Results: Overall, 161 subjects in the Novial® group and 73 subjects

in the control group completed the study. After 4 cycles, the total score for

sebum excretion decreased by 0.71 nl/cm2 (95% CI 0.36–1.05) in the

Novial® group and increased by 0.05 nl/cm2 (70.55–0.46) in the

control group. The difference between groups (0.78 nl/cm2 0.19–1.36) was

statistically significant (p=0.010). The number of active follicles/cm2

decreased by 0.86 (0.44–1.28) and 0.08 (70.53–0.69), respectively (mean (SD)

at baseline were 11.45 (2.23) and 11.19 (2.24) respectively). The difference

between the groups was statistically significant (p=0.029). The difference in

qualitative scores between the Novial® group and the control group (0.93 0.08–1.78)

was statistically significant (p=0.032). The average number of acne lesions

decreased in both groups, with a greater decrease seen in the Novial® group.

The subjects’ perception of their skin condition (0–100 rating)

significantly increased by 22.3 in the Novial® group (p=0.005), compared with

5.24 in the control group (ns). The physicians’ perception of the subjects’

skin also statistically significantly improved in the Novial® group (p=0.009).

Overall 19.3% of the subjects reported an AE (18.1% in the Novial® group, 22.1%

in the control group). In the Novial® group, four subjects (2.3%) discontinued

due to an AE. There were no pregnancies.

Conclusion: Novial® effectively reduces seborrhea after only 4 cycles

of treatment and may be a suitable oral contraceptive for women wishing to

improve their facial skin condition.

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