Acne VulgarisNCT03585140
Low Glycemic Index and Load Diet for the Treatment of Acne
A study testing Normal diet, Low glycemic diet and Adapalene 0.1% Gel in people with Acne Vulgaris and Diet Modification, run by Centro Dermatológico Dr. Ladislao de la Pascua.
Trial summary
Clinical trial to determine the effect of adding a diet with low glycemic index and load to adults for the treatment of moderate acne. Adult patients with acne where recruited in two groups, A and B. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men only
- Conditions the study is for
- Acne Vulgaris, Diet Modification
- What is being tested?
- Normal diet, Low glycemic diet and Adapalene 0.1% Gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Nov 2016
- 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 to 25 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Having moderate inflammatory acne
- 18 to 25 years old
- Male
- Stable weight during the last 3 months
Who cannot join
- Previous or actual isotretinoin therapy
- Antibiotic therapy or during the last 3 months
- Therapy based on peelings, dermabrasion, laser or intense pulsed light during the last 6 months
- Endocrine disorders
- Drug and alcohol consumption during the last 6 months
- Tabacco use during the last 6 months
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- Lactose intolerance
- Have eating disorders or gastrointestinal disorders
- Actual nutrition therapy
- Have chronic diseases that requires pharmacologic therapy
- Severe acne that requires isotretinoin therapy
About this study
Official title: Effect of Adding a Diet With Low Glycemic Index and Load During 12 Weeks for the Treatment of Moderate Acne in Adults: a Randomized Clinical Trial
Clinical trial to determine the effect of adding a diet with low glycemic index and load to adults for the treatment of moderate acne. Adult patients with acne where recruited in two groups, A and B. Group A received a normal diet according to their metabolic status and group B received a diet with low glycemic index and load. Outcomes were measured at week 12.
Read the detailed description
Clinical trial to determine the effect of adding a diet with low glycemic index and load to adults for the treatment of moderate acne. Adult patients with acne where recruited in two groups, A and B. Both groups of treatment were treated with doxycycline 100 mg per day plus adapalene 0.1% gel daily for 12 weeks. During pharmacologic treatment, all patients had nutrition counseling monthly. Group A received a normal diet according to their metabolic status and group B received a diet with low glycemic index and load. At the end of the trial, the change in acne lesions count was analyzed and also their metabolic status. Quality of life was also measured.
- Conditions
- Acne Vulgaris, Diet Modification
- Being tested
- Normal diet, Low glycemic diet, Adapalene 0.1% Gel, Doxycycline
- Keywords
- Acne Vulgaris, Low Glycemic Diet, Doxycycline, Adapalene
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal dietOther
The energy consumption of each of the participants will be calculated, using the Mifflin-St Jeor formula. Each participant will receive a standard menu of 6 days according to their metabolic requirements and a list of equivalent foods. The distribution of macronutrients will be: 45% carbohydrates, 30% lipids and 25% proteins.
Low glycemic dietOther
The energy consumption of each of the participants will be calculated, using the Mifflin-St Jeor formula. Each participant will receive a standard menu of 6 days according to their metabolic requirements and a list of equivalent foods. A list of foods classified as having low index and glycemic load was used according to the mexican equivalent food system. The distribution of macronutrients will be: 45% carbohydrates, 30% lipids and 25% proteins. Milk and vitamin supplements will be eliminated from the diet.
Adapalene 0.1% GelDrug
Also called Adapalene
Adapalene 0.1% gel daily at night for 12 weeks, applied on the face, chest and back.
DoxycyclineDrug
Doxycycline 100 mg per day orally, before breakfast
| Study group | Role | What they receive |
|---|---|---|
| Normal Diet | Active comparator | Participants will receive a normal diet according to their metabolic status. Receives: Other: Normal diet; Drug: Adapalene 0.1% Gel; Drug: Doxycycline |
| Low glycemic diet | Experimental | Participants will receive a low-glycemic index and load diet according to their metabolic status. Milk and vitamin supplements will be eliminated from the diet. Receives: Other: Low glycemic diet; Drug: Adapalene 0.1% Gel; Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of inflammatory acne lesions
Number of papules and pustules
Measured: 12 weeks
Secondary outcomes (2)
Count of non-inflammatory acne lesions
Number of comedones
Measured: 12 weeks
Changes in quality of life
Score of the Dermatology Life Quality Index
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start1 Jan 2016
- Primary completion1 May 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Randomized clinical trial, two-arm
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Dermatológico Dr. Ladislao de la Pascua
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dra. Martha Alejandra Morales Sánchez, Centro Dermatológico Dr. Ladislao de la Pascua
- Investigators
- Martha A Morales-Sánchez, MD, Principal investigator, Centro Dermatológico Dr. Ladislao de la Pascua
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585140
- Sponsor's protocol ID
- 106/2016
- Status last verified
- Jul 2018
- First submitted
- 29 Jun 2018
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding a Diet With Low Glycemic Index and Load During 12 Weeks for the Treatment of Moderate Acne in Adults: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03585140
- Acronym / sponsor ID
- 106/2016
- Conditions
- Acne Vulgaris, Diet Modification
- Keywords
- Acne Vulgaris, Low Glycemic Diet, Doxycycline, Adapalene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Centro Dermatológico Dr. Ladislao de la PascuaUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 12 Jul 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.
Clinical trial to determine the effect of adding a diet with low glycemic index and load to adults for the treatment of moderate acne. Adult patients with acne where recruited in two groups, A and B. Group A received a normal diet according to their metabolic status and group B received a diet with low glycemic index and load. Outcomes were measured at week 12.
Detailed description
Clinical trial to determine the effect of adding a diet with low glycemic index and load to adults for the treatment of moderate acne. Adult patients with acne where recruited in two groups, A and B. Both groups of treatment were treated with doxycycline 100 mg per day plus adapalene 0.1% gel daily for 12 weeks. During pharmacologic treatment, all patients had nutrition counseling monthly. Group A received a normal diet according to their metabolic status and group B received a diet with low glycemic index and load. At the end of the trial, the change in acne lesions count was analyzed and also their metabolic status. Quality of life was also measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial, two-arm
| Arm | Type | Receives |
|---|---|---|
| Normal Diet | Active comparator | Other: Normal diet, Drug: Adapalene 0.1% Gel, Drug: DoxycyclineParticipants will receive a normal diet according to their metabolic status. |
| Low glycemic diet | Experimental | Other: Low glycemic diet, Drug: Adapalene 0.1% Gel, Drug: DoxycyclineParticipants will receive a low-glycemic index and load diet according to their metabolic status. Milk and vitamin supplements will be eliminated from the diet. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Having moderate inflammatory acne
- 18 to 25 years old
- Male
- Stable weight during the last 3 months
Key exclusion criteria (11 listed)
- Previous or actual isotretinoin therapy
- Antibiotic therapy or during the last 3 months
- Therapy based on peelings, dermabrasion, laser or intense pulsed light during the last 6 months
- Endocrine disorders
- Drug and alcohol consumption during the last 6 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 |
|---|---|---|
| Normal dietThe energy consumption of each of the participants will be calculated, using the Mifflin-St Jeor formula. Each participant will receive a standard menu of 6 days according to their metabolic requirements and a list of equivalent foods. The distribution of macronutrients will be: 45% carbohydrates, 30% lipids and 25% proteins. | Other | Normal Diet |
| Low glycemic dietThe energy consumption of each of the participants will be calculated, using the Mifflin-St Jeor formula. Each participant will receive a standard menu of 6 days according to their metabolic requirements and a list of equivalent foods. A list of foods classified as having low index and glycemic load was used according to the mexican equivalent food system. The distribution of macronutrients will be: 45% carbohydrates, 30% lipids and 25% proteins. Milk and vitamin supplements will be eliminated from the diet. | Other | Low glycemic diet |
| Adapalene 0.1% GelAlso: AdapaleneAdapalene 0.1% gel daily at night for 12 weeks, applied on the face, chest and back. | Drug | Low glycemic diet, Normal Diet |
| DoxycyclineDoxycycline 100 mg per day orally, before breakfast | Drug | Low glycemic diet, Normal Diet |
Primary outcome
Count of inflammatory acne lesions
Time frame: 12 weeks
Number of papules and pustules
2 secondary outcomes
Count of non-inflammatory acne lesions
Time frame: 12 weeks
Changes in quality of life
Time frame: 12 weeks
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 Jul 2018.
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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.
Martha A Morales-Sánchez, MD principal investigator
Centro Dermatológico Dr. Ladislao de la Pascua
Questions about this trial
What is this clinical trial studying?
A study testing Normal diet, Low glycemic diet and Adapalene 0.1% Gel in people with Acne Vulgaris and Diet Modification, run by Centro Dermatológico Dr. Ladislao de la Pascua.
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 4 inclusion and 11 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 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Count of inflammatory acne lesions (time frame: 12 weeks). 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 16 Jul 2018.