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.
