Acne PapulopustulosaPhase 4NCT00237978
Control of Therapy of Acne Papulopustulosa by Visible Light With Waterfiltered Infrared and / or Adapalen (Differin Gel)
A Phase 4 study testing Adapalen and VIS and wIRA in people with Acne Papulopustulosa, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The aim of the study is to investigate the effectivity of visible light in combination with waterfiltered infrared in treating acne papulopustulosa. The reduction of inflammatory and non-inflammatory lesions within 8 weeks will be measured and compared with the standard treatment with Adapalene. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Acne Papulopustulosa
- What is being tested?
- Adapalen and VIS and wIRA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2006to Sep 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mild to moderate acne papulopustulosa according to Burton Scale Stage 3 to 4
- At least 5 inflammatory and 5 non-inflammatory lesions in the face
- Age >= 14 years
Who cannot join
- pregnant and nursing women
- Antiandrogen therapy
- therapy with antibiotics within the last 4 weeks
- therapy with retinoids within the last 6 months
- natural or artificial UV-therapy within the last 4 weeks
- severe acne papulopustulosa according to Burton Scale 5 or 6
- Severe systemic condition
- Secondary acne
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, Saxony, 01307
Roland Aschoff, MD, 0049-351-458 ext. 2007, Roland.Aschoff@mailbox.tu-dresden.de
About this study
The aim of the study is to investigate the effectivity of visible light in combination with waterfiltered infrared in treating acne papulopustulosa. The reduction of inflammatory and non-inflammatory lesions within 8 weeks will be measured and compared with the standard treatment with Adapalene.
- Conditions
- Acne Papulopustulosa
- Being tested
- Adapalen, VIS and wIRA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdapalenDrug
VIS and wIRARadiation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | VIS and wIRA Receives: Radiation: VIS and wIRA |
| 2 | Active comparator | VIS, wIRA and Adapalen Receives: Drug: Adapalen; Radiation: VIS and wIRA |
| 3 | Active comparator | Adapalen Receives: Drug: Adapalen |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of inflammatory and non-inflammatory lesions within 8 weeks after start of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
- Study startSep 2006
- Primary completionJun 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne PapulopustulosaStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Roland Aschoff, MD, Principal investigator, Technische Universität Dresden, Fetscher Str. 74, 01307 Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237978
- Sponsor's protocol ID
- TUD-Akne02-003
- Status last verified
- May 2008
- First submitted
- 12 Oct 2005
- Last updated
- 14 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Therapy of Acne Papulopustulosa by Visible Light With Waterfiltered Infrared and / or Adapalen (Differin Gel)
- ClinicalTrials.gov ID
- NCT00237978
- Acronym / sponsor ID
- TUD-Akne02-003
- Conditions
- Acne Papulopustulosa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 13 Oct 2005 (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.
The aim of the study is to investigate the effectivity of visible light in combination with waterfiltered infrared in treating acne papulopustulosa. The reduction of inflammatory and non-inflammatory lesions within 8 weeks will be measured and compared with the standard treatment with Adapalene.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Radiation: VIS and wIRAVIS and wIRA |
| 2 | Active comparator | Drug: Adapalen, Radiation: VIS and wIRAVIS, wIRA and Adapalen |
| 3 | Active comparator | Drug: AdapalenAdapalen |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Mild to moderate acne papulopustulosa according to Burton Scale Stage 3 to 4
- At least 5 inflammatory and 5 non-inflammatory lesions in the face
- Age >= 14 years
Key exclusion criteria (8 listed)
- pregnant and nursing women
- Antiandrogen therapy
- therapy with antibiotics within the last 4 weeks
- therapy with retinoids within the last 6 months
- natural or artificial UV-therapy within the last 4 weeks
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 |
|---|---|---|
| Adapalen | Drug | 2, 3 |
| VIS and wIRA | Radiation | 1, 2 |
Primary outcome
reduction of inflammatory and non-inflammatory lesions within 8 weeks after start of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2009.
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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
Technische Universität Dresden, Fetscher Str. 74, 01307 Dresden, Germany
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 Adapalen and VIS and wIRA in people with Acne Papulopustulosa, run by Technische Universität Dresden 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 May 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roland Aschoff, MD (0049-351-458 ext. 2007, Roland.Aschoff@mailbox.tu-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of inflammatory and non-inflammatory lesions within 8 weeks after start of therapy. 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 14 May 2009.