Oily SkinNCT05138835
BOTOX® Cosmetic and Skin Health.
A study testing Botox Cosmetic in people with Oily Skin, run by Andreas Nikolis at 1 site in Canada.
Trial summary
This is a two cohort, randomized, double blind, single center study to evaluate the effects of Botox Cosmetic (BTX) on sebum protection. Thirty-four female subjects with moderate-to-high skin sebum concentration will be recruited and randomized in a 1:1 ratio to treatment groups. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oily Skin
- What is being tested?
- Botox Cosmetic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 11 Nov 2021to 11 Dec 2022
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age above 18 years.
- Female sex.
- A SebumeterTM score >66ug/cm2 at Baseline.
- Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability and willingness to give consent to participate in the study.
- Signed and dated informed consent to participate in the study and unrestricted use of facial images for marketing purpose.
- If female of childbearing potential: a negative urine pregnancy test before all treatments is required.
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- Subject agrees to use the same topical cosmetic products (e.g., cleansers, moisturizers) throughout the duration of the trial, and at least for 30 days prior to enrolment.
- Subject is on a stable diet and is not planning any major dietary changes throughout the duration of the trial.
- Subject is not planning on undergoing any major hormonal changes throughout the duration of the study (e.g., menopause, change in medications).
Who cannot join
- Current Pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)];
- Patients meeting any official BOTOX® Cosmetic contra-indications;
- Inability to comply with follow-up and abstain from other treatments in the region of interest during the study period;
- Heavy smokers, classified as smoking more than 12 cigarettes per day;
- History of severe or multiple allergies manifested by anaphylaxis;
- Previous tissue revitalization therapy in the treatment area within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion;
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- Previous treatment with neurotoxins in the area under assessment, within 6 months prior to enrolment;
- Previous treatment with soft tissue fillers in the area under assessment, within 6 months prior to enrolment;
- Subjects presenting with known allergy to BOTOX® Cosmetic.
- Subjects presenting with porphyria.
- Subjects with active disease, such as inflammation, infection or tumors, in or near the intended treatment site.
- History of bleeding disorders or treatment with thrombolytics, anticoagulants, or inhibitors of platelet aggregation (e.g. Aspirin or other non-steroid anti-inflammatory drugs [NSAIDs]), within 2 weeks before treatment.
- Subjects using immunosuppressants.
- Subjects prescribed systematic or topical (in the area under assessment) antibiotics within 1 month of enrolment.
- Tattoos, piercings or visible markings that in the treating investigator's opinion, may interfere with results or assessments.
- Cancer or precancer in the treatment area, e.g. actinic keratosis.
- Patients with a tendency to form hypertrophic scars or any other healing disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind Evaluation of the Effects of BOTOX® Cosmetic on Skin Health
This is a two cohort, randomized, double blind, single center study to evaluate the effects of Botox Cosmetic (BTX) on sebum protection. Thirty-four female subjects with moderate-to-high skin sebum concentration will be recruited and randomized in a 1:1 ratio to treatment groups.
- Conditions
- Oily Skin
- Being tested
- Botox Cosmetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox CosmeticDrug
BOTOX® Cosmetic is approved and commercially available for use in Canada.
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe frown lines between the eyebrows, crow's feet lines, and forehead lines in adults.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Subjects will receive BTX in the glabella and forehead regions, using a traditional injection technique commonly utilized in aesthetic medicine. The traditional injection technique will deposit the neurotoxin into the targeted muscles; with up to 24 units being injected into the forehead and 20 units in the glabella. Receives: Drug: Botox Cosmetic |
| Group 2 | Experimental | Subjects will receive the traditional, deep injection technique, in addition to a superficial intradermal injection technique, which uses micro-aliquots of toxin. The superficial technique will deposit 0.1 units of toxin at 5mm intervals, at the level of the deep dermis. Receives: Drug: Botox Cosmetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin quality assessment
Reduction in sebum
Measured: Baseline versus Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start11 Nov 2021
- Primary completion11 Nov 2022
- Study completion11 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oily SkinStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andreas Nikolis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andreas Nikolis, Erevna Innovations Inc.
- Investigators
- Andreas Nikolis, Principal investigator, Erevna Innovations Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138835
- Sponsor's protocol ID
- 2020-ALG-BTX
- Status last verified
- May 2023
- First submitted
- 17 Nov 2021
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind Evaluation of the Effects of BOTOX® Cosmetic on Skin Health
- ClinicalTrials.gov ID
- NCT05138835
- Acronym / sponsor ID
- 2020-ALG-BTX
- Conditions
- Oily Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Andreas NikolisUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Dec 2022 (actual)
- First posted
- 1 Dec 2021 (actual)
- 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.
This is a two cohort, randomized, double blind, single center study to evaluate the effects of Botox Cosmetic (BTX) on sebum protection. Thirty-four female subjects with moderate-to-high skin sebum concentration will be recruited and randomized in a 1:1 ratio to treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Botox CosmeticSubjects will receive BTX in the glabella and forehead regions, using a traditional injection technique commonly utilized in aesthetic medicine. The traditional injection technique will deposit the neurotoxin into the targeted muscles; with up to 24 units being injected into the forehead and 20 units in the glabella. |
| Group 2 | Experimental | Drug: Botox CosmeticSubjects will receive the traditional, deep injection technique, in addition to a superficial intradermal injection technique, which uses micro-aliquots of toxin. The superficial technique will deposit 0.1 units of toxin at 5mm intervals, at the level of the deep dermis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age above 18 years.
- Female sex.
- A SebumeterTM score >66ug/cm2 at Baseline.
- Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability and willingness to give consent to participate in the study.
- Signed and dated informed consent to participate in the study and unrestricted use of facial images for marketing purpose.
Key exclusion criteria (17 listed)
- Current Pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)];
- Patients meeting any official BOTOX® Cosmetic contra-indications;
- Inability to comply with follow-up and abstain from other treatments in the region of interest during the study period;
- Heavy smokers, classified as smoking more than 12 cigarettes per day;
- History of severe or multiple allergies manifested by anaphylaxis;
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 |
|---|---|---|
| Botox CosmeticBOTOX® Cosmetic is approved and commercially available for use in Canada. BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe frown lines between the eyebrows, crow's feet lines, and forehead lines in adults. | Drug | Group 1, Group 2 |
Primary outcome
Skin quality assessment
Time frame: Baseline versus Week 4
Reduction in sebum
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 31 May 2023.
- Individual participant dataSharing planned: No
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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.
Andreas Nikolis principal investigator
Erevna Innovations Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botox Cosmetic in people with Oily Skin, run by Andreas Nikolis at 1 site in Canada.
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 9 inclusion and 17 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 31 May 2023. 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 Canada. 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.
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?
Skin quality assessment (time frame: Baseline versus Week 4). 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 31 May 2023.