search
Back to results

Pilot Study of Tolerability and Effectivity of Two Combination Topical Acne Products (PREFECT)

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Acnatac® Gel left face
Epiduo® Gel right face
Acnatac® Gel right face
Epiduo® Gel left face
Sponsored by
GWT-TUD GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne, vulgaris, Clindamycin, Tretinoin, Adapalen, Benzoylperoxid, Epiduo, Acnatac

Eligibility Criteria

14 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universitätsklinikum Carl Gustav Carus; Klinik und Poliklinik für Dermatologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Acnatac® Gel on left face and Epiduo® Gel on right face once daily for three weeks

Epiduo® Gel on left face and Acnatac® Gel on right face once daily for three weeks

Outcomes

Primary Outcome Measures

transepidermal water loss (TEWL)

Secondary Outcome Measures

Measuring the severity of burning/ stinging and itching using Study Subject Self-Assessment
Measuring and recording the number of acneiform lesions
Measuring health-related quality of life using DLQI-Score/CDLQI
Measuring skin surface pH using pH-Meter
Measuring skin sebum excretion using Sebumeter

Full Information

First Posted
March 29, 2016
Last Updated
October 22, 2018
Sponsor
GWT-TUD GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT02731105
Brief Title
Pilot Study of Tolerability and Effectivity of Two Combination Topical Acne Products
Acronym
PREFECT
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 21, 2017 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GWT-TUD GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne, vulgaris, Clindamycin, Tretinoin, Adapalen, Benzoylperoxid, Epiduo, Acnatac

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Acnatac® Gel on left face and Epiduo® Gel on right face once daily for three weeks
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Epiduo® Gel on left face and Acnatac® Gel on right face once daily for three weeks
Intervention Type
Drug
Intervention Name(s)
Acnatac® Gel left face
Other Intervention Name(s)
Clindamycin 1%, Tretinoin 0,025%
Intervention Description
topical application
Intervention Type
Drug
Intervention Name(s)
Epiduo® Gel right face
Other Intervention Name(s)
Adapalen 0,1% and Benzoylperoxid 2,5%
Intervention Description
topical application
Intervention Type
Drug
Intervention Name(s)
Acnatac® Gel right face
Other Intervention Name(s)
Clindamycin 1%, Tretinoin 0,025%
Intervention Description
topical application
Intervention Type
Drug
Intervention Name(s)
Epiduo® Gel left face
Other Intervention Name(s)
Adapalen 0,1% and Benzoylperoxid 2,5%
Intervention Description
topical application
Primary Outcome Measure Information:
Title
transepidermal water loss (TEWL)
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Measuring the severity of burning/ stinging and itching using Study Subject Self-Assessment
Time Frame
3 weeks
Title
Measuring and recording the number of acneiform lesions
Time Frame
3 weeks
Title
Measuring health-related quality of life using DLQI-Score/CDLQI
Time Frame
3 weeks
Title
Measuring skin surface pH using pH-Meter
Time Frame
3 weeks
Title
Measuring skin sebum excretion using Sebumeter
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Aschoff, MD
Organizational Affiliation
Uniklinikum Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Carl Gustav Carus; Klinik und Poliklinik für Dermatologie
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Pilot Study of Tolerability and Effectivity of Two Combination Topical Acne Products

We'll reach out to this number within 24 hrs