Acne Vulgaris Clinical Trial
Official title:
Pilot Study of Tolerability and Effectivity Following Application of Two Combination Topical Acne Products Clindamycin 1% and 0.025% Tretinoin Gel (Acnatac® Gel), Adapalen 0,1% and Benzoyl Peroxide 2,5% Gel (Epiduo® Gel)
Study to compare two gels that are used to treat acne vulgaris. It will be compared the tolerability and effectivity following application of two combination topical acne products clindamycin 1% and 0.025% tretinoin gel (Acnatac® Gel), adapalen 0,1% and benzoyl peroxide 2,5% gel (Epiduo® Gel).
At baseline, data will be collected regarding demographics and medical/medication histories,
lesions will be counted and a medical examination will be done. Female patients who could be
pregnant will be tested by using a pregnancy test. Each patient receives two tubes with
different medication that has to be applied on the left or right side of their face each by
themselves at home once a day(Acnatac® Gel, Duac® Gel, Epiduo® Gel).
Patients and study-center staff will be instructed not to reveal the treatment allocation to
the investigator, and patients will be instructed not to apply the product in their presence
Follow-up visits will be conducted on days 0, 7 and 21. On these days the investigator
measures erythema and dryness/scaling using the Investigators´Global Assessment, the severity
of burning/ stinging and itching by using Study Subject Self-Assessment, records the number
of acneiform lesions, measures health-related quality of life using DLQI-Score, skin
hydration using Corneometer, transepidermal water loss (TEWL) using Tewameter®, skin surface
pH using pH-Meter and skin sebum excretion using Sebumeter.
On days 0, 7, and 21 it will be collected information about current use of any other
medication. Adverse events (AEs) and serious adverse events (SAEs) will be monitored at each
visit. On day 21 there will be made a last pregnancy test. Checking compliance will be made
regularly.
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