Clinical trial NCT02731105: Pilot Study of Tolerability and Effectivity of Two Combination Topical Acne Products
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Keywords: acne
vulgaris
Clindamycin
Tretinoin
Adapalen
Benzoylperoxid
Epiduo
Acnatac
Lead sponsor: GWT-TUD GmbH
Sponsor class: OTHER
First posted: 2016-04-07
Enrollment: 22
Sex: ALL
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 childbearing years except post-menopausal (12 month natural amenorrhoea),

  ▪ postoperative (6 weeks after ovariectomy with or without hysterectomy)
* regularly and correct use of contraceptive with error rate \< 1 %/year
* no sex
* 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
* No concomitant participation in other studies within the past 30 days
* Hypersensitivity against any ingredients of Acnatac® -gel or Epiduo®gel
* Systemic medication with antibiotics or antibiotics within the last 4 weeks before study start
* Systemic medication with retinoids within the last 6 months before study start
* Topical treatment of acne vulgaris within the last two weeks before study
* Acne fulminans,
* Severe systemic disease respectively taking immunosuppressive drugs
* Severe liver disease
* Severe renal disease
* History or presence of regional enteritis or inflammatory bowel disease
* Other reasons that the doctor in charge decides about

Primary outcomes:
measure: transepidermal water loss (TEWL)
timeFrame: 3 weeks
Secondary outcomes:
measure: Measuring the severity of burning/ stinging and itching using Study Subject Self-Assessment
timeFrame: 3 weeks
measure: Measuring and recording the number of acneiform lesions
timeFrame: 3 weeks
measure: Measuring health-related quality of life using DLQI-Score/CDLQI
timeFrame: 3 weeks
measure: Measuring skin surface pH using pH-Meter
timeFrame: 3 weeks
measure: Measuring skin sebum excretion using Sebumeter
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus; Klinik und Poliklinik für Dermatologie
state: Saxony
Study officials:
affiliation: Uniklinikum Dresden
name: Roland Aschoff, MD
role: PRINCIPAL_INVESTIGATOR
References: