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

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ClinicalTrials.gov Identifier: NCT02731105
Recruitment Status : Completed
First Posted : April 7, 2016
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
GWT-TUD GmbH

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).

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Acnatac® Gel left face Drug: Epiduo® Gel right face Drug: Acnatac® Gel right face Drug: Epiduo® Gel left face Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : February 2015
Actual Primary Completion Date : February 21, 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Clindamycin

Arm Intervention/treatment
Active Comparator: Arm 1
Acnatac® Gel on left face and Epiduo® Gel on right face once daily for three weeks
Drug: Acnatac® Gel left face
topical application
Other Name: Clindamycin 1%, Tretinoin 0,025%

Drug: Epiduo® Gel right face
topical application
Other Name: Adapalen 0,1% and Benzoylperoxid 2,5%

Active Comparator: Arm 2
Epiduo® Gel on left face and Acnatac® Gel on right face once daily for three weeks
Drug: Acnatac® Gel right face
topical application
Other Name: Clindamycin 1%, Tretinoin 0,025%

Drug: Epiduo® Gel left face
topical application
Other Name: Adapalen 0,1% and Benzoylperoxid 2,5%




Primary Outcome Measures :
  1. transepidermal water loss (TEWL) [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Measuring the severity of burning/ stinging and itching using Study Subject Self-Assessment [ Time Frame: 3 weeks ]
  2. Measuring and recording the number of acneiform lesions [ Time Frame: 3 weeks ]
  3. Measuring health-related quality of life using DLQI-Score/CDLQI [ Time Frame: 3 weeks ]
  4. Measuring skin surface pH using pH-Meter [ Time Frame: 3 weeks ]
  5. Measuring skin sebum excretion using Sebumeter [ Time Frame: 3 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731105


Locations
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Germany
Universitätsklinikum Carl Gustav Carus; Klinik und Poliklinik für Dermatologie
Dresden, Saxony, Germany, 01307
Sponsors and Collaborators
GWT-TUD GmbH
Investigators
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Principal Investigator: Roland Aschoff, MD Uniklinikum Dresden

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Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT02731105     History of Changes
Other Study ID Numbers: PREFECT-trial
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Keywords provided by GWT-TUD GmbH:
acne
vulgaris
Clindamycin
Tretinoin
Adapalen
Benzoylperoxid
Epiduo
Acnatac
Additional relevant MeSH terms:
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Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Adapalene, Benzoyl Peroxide Drug Combination
Tretinoin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents