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).

GWT-TUD GmbH0 sitesAugust 13, 2015

Overview

No summary available.

Registry

who.int

Start Date

August 13, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Diagnosis of mild to moderate facial acne vulgaris at baseline\- Age: 14 years to 50 years
•\- No evidence of facial irritation (erythema, dryness/scaling,
•burning/itching/stinging) that is not typical for acne vulgaris
•\-Willingness to take part in acne study including screening visit and follow up visits on day 0,7, and 21
•\-No use of systemic antibiotics, steroids, retinoids and keratolytics within the last 30 days before start of the acne study
•\-Patients have to sign personally consent form and follow study procedures
•\-Patient is in good general health
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•Female patients who were pregnant, planning to become pregnant or breastfeeding
•\-Sexually active female subjects do not use a medically acceptable form of contraception (oral contraception, injectable or implantable methods or intrauterine devices)
•\- Female patients who are in childbreaking years except
•post\-menopausal (12 Monate natürliche Amenorrhoe),
•? postoperative (6 weeks after ovariectomy with or without hysterectomy)
•\-regulary and correct use of contraceptive with error rate \< 1 %/year
•\- vasectomy of the partner
•\- Diseases of the facial skin other than acne
•\-No concomitant topical medications (including make\-up) or keratolytics as sulphur, salicylic acid, benzoyl peroxide, resorcin and abradents and acid\-containing peels one week before the study starts
•\-Patients who had facial procedures (chemical peel, laser therapy, photodynamic therapy, microdermabrasion, or UV light therapy) within the past 4 weeks