Acne VulgarisNCT01969175
Effect of a Low-glycemic-load and Milk-free Diet on Acne Severity
A study testing Low-glycemic-load and milk-free diet in people with Acne Vulgaris, run by Parc Taulí Hospital Universitari at 1 site in Spain.
Trial summary
The objective of this study is to assess the effect of a low-glycemic-load and milk-free diet on acne severity. IGF-1 and a phosphorylated product of the mTORC pathway (p70S6K) will be assessed in both groups to explore the mTORC signaling pathway, which is thought to be related to clinical improvement in previous… Read more about this study
- Who is it for?
- Ages 14 to 20 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Low-glycemic-load and milk-free diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2013to Jul 2014
- 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 14 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Mild, moderate or severe acne (GAGS score 15-44)
- Age: 14-20 years old
- Presence of acne for at least 2 months
Who cannot join
- Diabetes
- Polycystic ovary syndrome
- Use of hormonal contraceptives
- Previous use of oral retinoids
- Use of oral antibiotics or topical antibacterial or retinoid agents in the last 2 months
- Use of medications known to cause or exacerbate acne including lithium, oral or injected retinoids, some anticonvulsant drugs, medications containing iodides or bromides
Show all 9Show fewer
- Drug or alcohol abuse.
- Active smokers
- Anticipated difficulty attending visits or fear of blood draws
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Parc Taulí
Sabadell, Barcelona, 08208
Lorena Leal, Medical Doctor
About this study
The objective of this study is to assess the effect of a low-glycemic-load and milk-free diet on acne severity.
IGF-1 and a phosphorylated product of the mTORC pathway (p70S6K) will be assessed in both groups to explore the mTORC signaling pathway, which is thought to be related to clinical improvement in previous studies.
- Conditions
- Acne Vulgaris
- Being tested
- Low-glycemic-load and milk-free diet
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-glycemic-load and milk-free dietOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention Diet | Experimental | Not described Receives: Other: Low-glycemic-load and milk-free diet |
| Control | Placebo comparator | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAGS Acne severity scale
Measured: 13 weeks
Secondary outcomes (3)
Serum insulin like growth factor 1 (IGF-1)
Measured: 13 weeks
Diet acceptability and adherence
Measured: 13 weeks
p70S6K
A phosphorylated product of mTORC signaling pathway
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc Taulí Hospital Universitari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorena Leal, MD, Parc Taulí Hospital Universitari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969175
- Sponsor's protocol ID
- HPT 2013-059
- Status last verified
- Nov 2013
- First submitted
- 21 Oct 2013
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kwon HH, Yoon JY, Hong JS, Jung JY, Park MS, Suh DH. Clinical and histological effect of a low glycaemic load diet in treatment of acne vulgaris in Korean patients: a randomized, controlled trial. Acta Derm Venereol. 2012 May;92(3):241-6. doi: 10.2340/00015555-1346.
PubMed 22678562Smith RN, Mann NJ, Braue A, Makelainen H, Varigos GA. A low-glycemic-load diet improves symptoms in acne vulgaris patients: a randomized controlled trial. Am J Clin Nutr. 2007 Jul;86(1):107-15. doi: 10.1093/ajcn/86.1.107.
PubMed 17616769Reynolds RC, Lee S, Choi JY, Atkinson FS, Stockmann KS, Petocz P, Brand-Miller JC. Effect of the glycemic index of carbohydrates on Acne vulgaris. Nutrients. 2010 Oct;2(10):1060-72. doi: 10.3390/nu2101060. Epub 2010 Oct 18.
PubMed 22253996
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Low-glycemic-load and Milk-free Diet on Acne Severity
- ClinicalTrials.gov ID
- NCT01969175
- Acronym / sponsor ID
- HPT 2013-059
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Parc Taulí Hospital UniversitariUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (estimated)
- First posted
- 25 Oct 2013 (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 objective of this study is to assess the effect of a low-glycemic-load and milk-free diet on acne severity.
IGF-1 and a phosphorylated product of the mTORC pathway (p70S6K) will be assessed in both groups to explore the mTORC signaling pathway, which is thought to be related to clinical improvement in previous studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Diet | Experimental | Other: Low-glycemic-load and milk-free diet |
| Control | Placebo comparator | – |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Mild, moderate or severe acne (GAGS score 15-44)
- Age: 14-20 years old
- Presence of acne for at least 2 months
Key exclusion criteria (9 listed)
- Diabetes
- Polycystic ovary syndrome
- Use of hormonal contraceptives
- Previous use of oral retinoids
- Use of oral antibiotics or topical antibacterial or retinoid agents in the last 2 months
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 |
|---|---|---|
| Low-glycemic-load and milk-free diet | Other | Intervention Diet |
Primary outcome
GAGS Acne severity scale
Time frame: 13 weeks
3 secondary outcomes
Serum insulin like growth factor 1 (IGF-1)
Time frame: 13 weeks
Diet acceptability and adherence
Time frame: 13 weeks
p70S6K
Time frame: 13 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
- Results publication: PubMed 22678562Kwon HH, Yoon JY, Hong JS, Jung JY, Park MS, Suh DH. Clinical and histological effect of a low glycaemic load diet in treatment of acne vulgaris in Korean patients: a randomized, controlled trial. Acta Derm Venereol. 2012 May;92(3):241-6. doi: 10.2340/00015555-1346.
- Results publication: PubMed 17616769Smith RN, Mann NJ, Braue A, Makelainen H, Varigos GA. A low-glycemic-load diet improves symptoms in acne vulgaris patients: a randomized controlled trial. Am J Clin Nutr. 2007 Jul;86(1):107-15. doi: 10.1093/ajcn/86.1.107.
- Results publication: PubMed 22253996Reynolds RC, Lee S, Choi JY, Atkinson FS, Stockmann KS, Petocz P, Brand-Miller JC. Effect of the glycemic index of carbohydrates on Acne vulgaris. Nutrients. 2010 Oct;2(10):1060-72. doi: 10.3390/nu2101060. Epub 2010 Oct 18.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-glycemic-load and milk-free diet in people with Acne Vulgaris, run by Parc Taulí Hospital Universitari at 1 site in Spain.
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 9 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 11 Nov 2013. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorena Leal, Medical Doctor (+34653358555, lorenalealcanosa@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GAGS Acne severity scale (time frame: 13 weeks). 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 NCT01969175, which also lists 3 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 11 Nov 2013.