Acne VulgarisPhase 2NCT00765375
Safety and Efficacy of the Use of Botox on Acne
A Phase 2 study testing Botulinum Neurotoxin Type A and Bacteriostatic saline in people with Acne Vulgaris, run by DeNova Research at 1 site in United States.
Trial summary
To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA) Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Botulinum Neurotoxin Type A and Bacteriostatic saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between the age of 18 and 50 years of age
- Not pregnant and negative pregnancy test, not planning on getting pregnant
- Mild to moderate bilateral acne lesions on the face
- Able to understand the requirements of the study and sign an Informed Consent Form
- Have the time and ability to complete the study and comply with instructions(i.e will be around for the duration of the study)
- Skin types I, II, III, IV and V
Who cannot join
- Subject has skin type VI
- Subject has a significant concurrent illness, such as diabetes, epilepsy, lupus or congestive heart disease
- Concurrent skin conditions affecting area to be treated
- Prior exposure to any serotype of botulinum toxin for any purpose in the 3 months immediately prior to study enrollment
- Prior surgery on the area to be treated within 3 months of initial treatment or during this clinical evaluation
- Open laceration, abrasion active cold sores or herpes sores, multiple dysplastic nevi in areas to be treated?
Show all 16Show fewer
- Permanent or semi-permanent dermal filler treatment within the last 6 months
- Medium or deep depth chemical peel resurfacing procedure within 3 months of treatment or during this clinical evaluation
- Has used oral isotretinoin (Accutane) within 6 months, or use of topical isotretinoin within 3 months, of initial treatment or during this clinical evaluation
- Prior light /laser treatments at target locations within 3 months of enrollment or during the course of this clinical evaluation
- Any physical or mental condition which, in the investigator's opinion would make it unsafe for the subject to participate in the clinical evaluation
- Use of oral antibiotics for acne and/or medication that cause photosensitivity within 2 weeks of initial treatment
- Participation in a study of another investigational devices or drugs within 3 months of enrollment
- Subject shows symptoms of a hormonal disorder
- Subject cannot be treated for (past or present) any form of treatment of active cancer or having a history of skin cancer or any other cancer in the area to be treated
- Subject is currently using immunosuppressive medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-Blind, Randomized, Placebo-Controlled Study to Determine the Safety and the Efficacy of Using Botulinum Neurotoxin Type A Injections for Subjects With Mild to Moderate Acne Vulgaris
- To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA)
Read the detailed description
- 90 day trial, with botox being injected at baseline/screening visit. Photos will be taken throughout the study and patients will be evaluated by masked injector evaluator and a masked evaluator. Patient will complete a subject evaluation at each visit. Follow-up visits occur at Day 3, 7, 14, 30 and 90.
- Conditions
- Acne Vulgaris
- Being tested
- Botulinum Neurotoxin Type A, Bacteriostatic saline
- Keywords
- acne, Botox, cosmetic treatments
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Neurotoxin Type ADrug
Also called Botox
1.5-3 units of Botox/lesion
Bacteriostatic salineDrug
.1 cc bacteriostatic saline/lesion
| Study group | Role | What they receive |
|---|---|---|
| Botox and Placebo on each side of face | Experimental | Botulinum Neurotoxin Type A (Botox, 1.5-3 units/lesion); Bacteriostatic saline solution (0.11 cc/lesion) Receives: Drug: Botulinum Neurotoxin Type A; Drug: Bacteriostatic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Lesion Count From Baseline at 90 Days
To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA)
Measured: Baseline and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Investigator decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- DeNova Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven H. Dayan, DeNova Research
- Investigators
- Steven H Dayan, MD F.A.C.S., Principal investigator, DeNova Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765375
- Sponsor's protocol ID
- BTX-D-001
- Status last verified
- May 2018
- First submitted
- 30 Sep 2008
- Last updated
- 29 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Placebo-Controlled Study to Determine the Safety and the Efficacy of Using Botulinum Neurotoxin Type A Injections for Subjects With Mild to Moderate Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00765375
- Acronym / sponsor ID
- BTX-D-001
- Conditions
- Acne Vulgaris
- Keywords
- acne, Botox, cosmetic treatments
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator decision
- Enrolment
- 5 participants (actual)
- Lead sponsor
- DeNova ResearchUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 2 Oct 2008 (estimated)
- Results
- Posted 30 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA)
Detailed description
- 90 day trial, with botox being injected at baseline/screening visit. Photos will be taken throughout the study and patients will be evaluated by masked injector evaluator and a masked evaluator. Patient will complete a subject evaluation at each visit. Follow-up visits occur at Day 3, 7, 14, 30 and 90.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botox and Placebo on each side of face | Experimental | Drug: Botulinum Neurotoxin Type A, Drug: Bacteriostatic salineBotulinum Neurotoxin Type A (Botox, 1.5-3 units/lesion); Bacteriostatic saline solution (0.11 cc/lesion) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Between the age of 18 and 50 years of age
- Not pregnant and negative pregnancy test, not planning on getting pregnant
- Mild to moderate bilateral acne lesions on the face
- Able to understand the requirements of the study and sign an Informed Consent Form
- Have the time and ability to complete the study and comply with instructions(i.e will be around for the duration of the study)
Key exclusion criteria (16 listed)
- Subject has skin type VI
- Subject has a significant concurrent illness, such as diabetes, epilepsy, lupus or congestive heart disease
- Concurrent skin conditions affecting area to be treated
- Prior exposure to any serotype of botulinum toxin for any purpose in the 3 months immediately prior to study enrollment
- Prior surgery on the area to be treated within 3 months of initial treatment or during this clinical evaluation
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 |
|---|---|---|
| Botulinum Neurotoxin Type AAlso: Botox1.5-3 units of Botox/lesion | Drug | Botox and Placebo on each side of face |
| Bacteriostatic saline.1 cc bacteriostatic saline/lesion | Drug | Botox and Placebo on each side of face |
Primary outcome
Change in Mean Lesion Count From Baseline at 90 Days
Time frame: Baseline and 90 days
To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Steven H Dayan, MD F.A.C.S. principal investigator
DeNova Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum Neurotoxin Type A and Bacteriostatic saline in people with Acne Vulgaris, run by DeNova Research at 1 site in United States.
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 6 inclusion and 16 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: stopped early, as of the sponsor's last update on 29 Jun 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Mean Lesion Count From Baseline at 90 Days (time frame: Baseline and 90 days). 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 29 Jun 2018.