Acne VulgarisPhase 4PREFECTNCT02731105
Pilot Study of Tolerability and Effectivity of Two Combination Topical Acne Products
A Phase 4 study testing Acnatac® Gel left face, Epiduo® Gel right face and Acnatac® Gel right face in people with Acne Vulgaris, run by GWT-TUD GmbH at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Acnatac® Gel left face, Epiduo® Gel right face and Acnatac® Gel right face
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Carl Gustav Carus; Klinik und Poliklinik für Dermatologie
Dresden, Saxony, 01307
About this study
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).
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- Acnatac® Gel left face, Epiduo® Gel right face, Acnatac® Gel right face, Epiduo® Gel left face
- Keywords
- acne, vulgaris, Clindamycin, Tretinoin, Adapalen, Benzoylperoxid, Epiduo, Acnatac
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acnatac® Gel left faceDrug
Also called Clindamycin 1%, Tretinoin 0,025%
topical application
Epiduo® Gel right faceDrug
Also called Adapalen 0,1% and Benzoylperoxid 2,5%
topical application
Acnatac® Gel right faceDrug
Also called Clindamycin 1%, Tretinoin 0,025%
topical application
Epiduo® Gel left faceDrug
Also called Adapalen 0,1% and Benzoylperoxid 2,5%
topical application
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Acnatac® Gel on left face and Epiduo® Gel on right face once daily for three weeks Receives: Drug: Acnatac® Gel left face; Drug: Epiduo® Gel right face |
| Arm 2 | Active comparator | Epiduo® Gel on left face and Acnatac® Gel on right face once daily for three weeks Receives: Drug: Acnatac® Gel right face; Drug: Epiduo® Gel left face |
What is being measured
The primary outcome is the main question the study is designed to answer.
transepidermal water loss (TEWL)
Measured: 3 weeks
Secondary outcomes (5)
Measuring the severity of burning/ stinging and itching using Study Subject Self-Assessment
Measured: 3 weeks
Measuring and recording the number of acneiform lesions
Measured: 3 weeks
Measuring health-related quality of life using DLQI-Score/CDLQI
Measured: 3 weeks
Measuring skin surface pH using pH-Meter
Measured: 3 weeks
Measuring skin sebum excretion using Sebumeter
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startFeb 2015
- Primary completion21 Feb 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- GWT-TUD GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland Aschoff, MD, Principal investigator, Uniklinikum Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731105
- Sponsor's protocol ID
- PREFECT-trial
- Acronym
- PREFECT
- Status last verified
- Oct 2018
- First submitted
- 29 Mar 2016
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02731105
- Acronym / sponsor ID
- PREFECT / PREFECT-trial
- Conditions
- Acne Vulgaris
- Keywords
- acne, vulgaris, Clindamycin, Tretinoin, Adapalen, Benzoylperoxid, Epiduo, Acnatac
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- GWT-TUD GmbHUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 21 Feb 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 7 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Acnatac® Gel left face, Drug: Epiduo® Gel right faceAcnatac® Gel on left face and Epiduo® Gel on right face once daily for three weeks |
| Arm 2 | Active comparator | Drug: Acnatac® Gel right face, Drug: Epiduo® Gel left faceEpiduo® Gel on left face and Acnatac® Gel on right face once daily for three weeks |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (21 listed)
- 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),
- regularly and correct use of contraceptive with error rate < 1 %/year
- no sex
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acnatac® Gel left faceAlso: Clindamycin 1%, Tretinoin 0,025%topical application | Drug | Arm 1 |
| Epiduo® Gel right faceAlso: Adapalen 0,1% and Benzoylperoxid 2,5%topical application | Drug | Arm 1 |
| Acnatac® Gel right faceAlso: Clindamycin 1%, Tretinoin 0,025%topical application | Drug | Arm 2 |
| Epiduo® Gel left faceAlso: Adapalen 0,1% and Benzoylperoxid 2,5%topical application | Drug | Arm 2 |
Primary outcome
transepidermal water loss (TEWL)
Time frame: 3 weeks
5 secondary outcomes
Measuring the severity of burning/ stinging and itching using Study Subject Self-Assessment
Time frame: 3 weeks
Measuring and recording the number of acneiform lesions
Time frame: 3 weeks
Measuring health-related quality of life using DLQI-Score/CDLQI
Time frame: 3 weeks
Measuring skin surface pH using pH-Meter
Time frame: 3 weeks
Measuring skin sebum excretion using Sebumeter
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland Aschoff, MD principal investigator
Uniklinikum Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acnatac® Gel left face, Epiduo® Gel right face and Acnatac® Gel right face in people with Acne Vulgaris, run by GWT-TUD GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
transepidermal water loss (TEWL) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.