CaffeinePhase 2/3NCT03556917
The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.
A Phase 2/3 study testing iontophoresis + caffeine in people with Caffeine and Cellulitis, run by Universidade Norte do Paraná at 1 site in Brazil.
Trial summary
Introduction: Gynoid hydrolipodystrophy (HLDG) or cellulitis is a subcutaneous tissue disorder, with several strategies for its treatment, such as caffeine and iontophoresis. Objective: To evaluate the effects of caffeine-associated iontophoresis for the treatment of HLDG. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Caffeine, Cellulitis
- What is being tested?
- iontophoresis + caffeine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Jun 2018to 4 Apr 2019
- Phase
- Phase 2/3
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with mild to moderate cellulite diagnosis will be included, according to the validated Photonumeric scale of cellulite severity
- Body mass index less than 30 (kg / m2)
Who cannot join
- Individuals who have a deregulated menstrual cycle who are pregnant;
- Breastfeeding or using some hormone;
- Antibiotic medication including steroids over 1 month of treatment of skin diseases; •Sensitivity or hypersensitivity of the skin;
- Use of the same or similar cosmetics or remedies on the glutes within 1 month;
- Surgical procedure (liposuction and skin treatments) in the region to be treated or planning some procedure within the study period;
- Chronic debilitating diseases such as asthma, diabetes or hypertension;
- Atopic dermatitis
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: Gynoid hydrolipodystrophy (HLDG) or cellulitis is a subcutaneous tissue disorder, with several strategies for its treatment, such as caffeine and iontophoresis. Objective: To evaluate the effects of caffeine-associated iontophoresis for the treatment of HLDG. Methods: In a longitudinal study, participants will be evaluated for: photographic documentation, ultrasound imaging, thermography and quality of life questionnaire. If included, they will be separated into 3 randomized groups (n = 30). G1: use of base gel (n = 10); G2: use of iontophoresis and gel with caffeine (n = 10) and G3: use of iontophoresis alone (n = 10). The groups will be treated with 10 sessions, 2 times per week. After that they will be reevaluated. Statistical analysis: The software used will be the SPSS StatisticalPackage (IBM SPSS Statistics, Chicago, IL, USA). The data distribution will be analyzed by the Shapiro-Wilk test. In case of normal distribution, the data will be described as mean ± standard deviation; otherwise, as median [interquartile range 25-75%]. For comparison of the data, we will use ANOVA and for comparison of means the Tukey test and case not normal distribution, krulskal-Wallis test and the Dunns test. The level of statistical significance adopted will be P <0.05. Expected contributions: It is expected that investigators can contribute to the treatment of patients with HLDG and analyze the effects of iontophoresis with caffeine, both in clinical and scientific practice, providing a method that is valid and reliable for this purpose; multidisciplinary training of highly qualified human resources and the strengthening and consolidation of a research team.
- Conditions
- Caffeine, Cellulitis
- Being tested
- iontophoresis + caffeine
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iontophoresis + caffeineCombination product
we will use cafeislaine c (caffeine) +galvanic current
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | topical gel base + caffeine. Receives: Combination Product: iontophoresis + caffeine |
| group 2 | Active comparator | iontophoresis + caffeine Receives: Combination Product: iontophoresis + caffeine |
| Group 3 | Active comparator | iontophoresis Receives: Combination Product: iontophoresis + caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
thickness
change from baseline subcutaneous adipose tissue thickness at after 10 sessions
Measured: through study completion, an average of 1 year.
Secondary outcomes (2)
temperature
change from baseline superficial temperature of the gluteous skin at after 10 sessions
Measured: through study completion, an average of 1 year.
score quality of life
change from baseline quality of life impact in patients with cellulits at after 10 sessions
Measured: through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start14 Jun 2018
- Primary completion17 Mar 2019
- Study completion4 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CaffeineStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- It is a longitudinal and randomized
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Norte do Paraná
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alana Roberta Quessada, Universidade Norte do Paraná
- Investigators
- Rodrigo A Andraus, Principal investigator, Universidade Norte do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556917
- Sponsor's protocol ID
- 2.264.773
- Status last verified
- Apr 2019
- First submitted
- 15 May 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hexsel DM, Dal'forno T, Hexsel CL. A validated photonumeric cellulite severity scale. J Eur Acad Dermatol Venereol. 2009 May;23(5):523-8. doi: 10.1111/j.1468-3083.2009.03101.x. Epub 2009 Feb 13.
PubMed 19220646Yoo MA, Seo YK, Ryu JH, Back JH, Koh JS. A validation study to find highly correlated parameters with visual assessment for clinical evaluation of cosmetic anti-cellulite products. Skin Res Technol. 2014 May;20(2):200-7. doi: 10.1111/srt.12106. Epub 2013 Sep 7.
PubMed 24010809
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Iontophoresis in Women With Gynoid Hidrolipodystrophy.
- ClinicalTrials.gov ID
- NCT03556917
- Acronym / sponsor ID
- 2.264.773
- Conditions
- Caffeine, Cellulitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade Norte do ParanáUniversity, hospital or other
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 17 Mar 2019 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 14 Jun 2018 (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.
Introduction: Gynoid hydrolipodystrophy (HLDG) or cellulitis is a subcutaneous tissue disorder, with several strategies for its treatment, such as caffeine and iontophoresis. Objective: To evaluate the effects of caffeine-associated iontophoresis for the treatment of HLDG. Methods: In a longitudinal study, participants will be evaluated for: photographic documentation, ultrasound imaging, thermography and quality of life questionnaire. If included, they will be separated into 3 randomized groups (n = 30). G1: use of base gel (n = 10); G2: use of iontophoresis and gel with caffeine (n = 10) and G3: use of iontophoresis alone (n = 10). The groups will be treated with 10 sessions, 2 times per week. After that they will be reevaluated. Statistical analysis: The software used will be the SPSS StatisticalPackage (IBM SPSS Statistics, Chicago, IL, USA). The data distribution will be analyzed by the Shapiro-Wilk test. In case of normal distribution, the data will be described as mean ± standard deviation; otherwise, as median [interquartile range 25-75%]. For comparison of the data, we will use ANOVA and for comparison of means the Tukey test and case not normal distribution, krulskal-Wallis test and the Dunns test. The level of statistical significance adopted will be P <0.05. Expected contributions: It is expected that investigators can contribute to the treatment of patients with HLDG and analyze the effects of iontophoresis with caffeine, both in clinical and scientific practice, providing a method that is valid and reliable for this purpose; multidisciplinary training of highly qualified human resources and the strengthening and consolidation of a research team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- It is a longitudinal and randomized
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Combination Product: iontophoresis + caffeinetopical gel base + caffeine. |
| group 2 | Active comparator | Combination Product: iontophoresis + caffeineiontophoresis + caffeine |
| Group 3 | Active comparator | Combination Product: iontophoresis + caffeineiontophoresis |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with mild to moderate cellulite diagnosis will be included, according to the validated Photonumeric scale of cellulite severity
- Body mass index less than 30 (kg / m2)
Key exclusion criteria (7 listed)
- Individuals who have a deregulated menstrual cycle who are pregnant;
- Breastfeeding or using some hormone;
- Antibiotic medication including steroids over 1 month of treatment of skin diseases; •Sensitivity or hypersensitivity of the skin;
- Use of the same or similar cosmetics or remedies on the glutes within 1 month;
- Surgical procedure (liposuction and skin treatments) in the region to be treated or planning some procedure within the study period;
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 |
|---|---|---|
| iontophoresis + caffeinewe will use cafeislaine c (caffeine) +galvanic current | Combination product | Group 3, group 1, group 2 |
Primary outcome
thickness
Time frame: through study completion, an average of 1 year.
change from baseline subcutaneous adipose tissue thickness at after 10 sessions
2 secondary outcomes
temperature
Time frame: through study completion, an average of 1 year.
score quality of life
Time frame: through study completion, an average of 1 year.
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 16 Apr 2019.
- Results publication: PubMed 19220646Hexsel DM, Dal'forno T, Hexsel CL. A validated photonumeric cellulite severity scale. J Eur Acad Dermatol Venereol. 2009 May;23(5):523-8. doi: 10.1111/j.1468-3083.2009.03101.x. Epub 2009 Feb 13.
- Results publication: PubMed 24010809Yoo MA, Seo YK, Ryu JH, Back JH, Koh JS. A validation study to find highly correlated parameters with visual assessment for clinical evaluation of cosmetic anti-cellulite products. Skin Res Technol. 2014 May;20(2):200-7. doi: 10.1111/srt.12106. Epub 2013 Sep 7.
- 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.
Rodrigo A Andraus principal investigator
Universidade Norte do Paraná
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing iontophoresis + caffeine in people with Caffeine and Cellulitis, run by Universidade Norte do Paraná at 1 site in Brazil.
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 2 inclusion and 7 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 16 Apr 2019. 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 Brazil. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
thickness (time frame: through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03556917, which also lists 2 linked publications.
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 16 Apr 2019.