An interventional study of Mediterranean Diet Counseling and Mediterranean Food Support in Hidradenitis Suppurativa, sponsored by University of North Carolina, Chapel Hill. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Health services research
Among 161 studies in Hidradenitis Suppurativa with a site in United States — 38 open to participants now, 55 under way, 12 of them phase 3. Hidradenitis Suppurativa · United States.
Among the 161 studies in Hidradenitis Suppurativa with a site in United States, this one is the 81st largest by planned enrollment of the 139 interventional ones that give a count, is one of 17 that started in 2026, is one of 27 with no phase, reaches primary completion later than 26 of the 54 other live ones, and was the 157th registered.
285 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.
Browse Hidradenitis Suppurativa studies →38 of the 161 studies in Hidradenitis Suppurativa with a site in United States are open now. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in United States
Ages 18+
Novartis Pharmaceuticals · Sites in United States
Ages 18–65
Corvus Pharmaceuticals, Inc. · Sites in United States
Ages 18+
Harrison Dermatology · Sites in United States
Ages 12+
Beth Israel Deaconess Medical Center · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 61 Hidradenitis Suppurativa studies recruiting now, 33 (54%) set no upper age limit and 17 (28%) stop at 75 or younger; 13 take children under 18; 12 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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161 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 19 · Phase 2 65 · Phase 3 27 · Phase 4 5
First in 2005; this study’s year is marked. 17 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 45 across 200 interventional studies indexed under Hidradenitis Suppurativa.
Median enrollment 45 across the 139 interventional studies, 300 across the 22 observational. Of the 95 that completed or were terminated, 52 (55%) have results posted.
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87 of 161 have an industry lead sponsor. The 10 most frequent:
University of North Carolina, Chapel Hill is the lead sponsor of 1,373 studies on the registry; 134 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
University of North Carolina, Chapel Hill has 4 studies filed under Hidradenitis Suppurativa — fewer than ten, so there is no comparison to draw.
21 of the studies in Hidradenitis Suppurativa with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06468228Phase 3AbbVieA Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa | 2026-12 |
| NCT06921850Phase 3UCB Biopharma SRLA Study to Assess the Pharmacokinetics and Safety of Bimekizumab in Children and Adolescents With Moderate to Severe Hidradenitis Suppurativa | 2026-12-21 |
| NCT06212999Phase 3Incyte CorporationA Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa | 2026-12-26 |
| NCT06799000Phase 3Novartis PharmaceuticalsA Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1) | 2027-05-17 |
| NCT06840392Phase 3Novartis PharmaceuticalsA Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa | 2027-06-03 |
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Among the 161 studies in Hidradenitis Suppurativa with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to learn whether a 16-week Mediterranean-style dietary counseling program, called the Med-South Lifestyle Program (MSLP), is practical and acceptable for adults with hidradenitis suppurativa (HS). The study will also look at whether participants' Mediterranean diet adherence changes during the program.
The main questions it aims to answer are:
Participants will:
This study involves a 16-week Mediterranean-style eating program for people with hidradenitis suppurativa (HS). The program is called the Med-South Lifestyle Program (MSLP) and is designed to support practical, realistic dietary changes.
Most study activities are completed remotely. Participants will have two in-person visits, at the beginning and end of the study, usually scheduled after a regular dermatology appointment to avoid an extra clinic trip.
Participants will receive one-on-one nutrition counseling by video call from dietetic students supervised by a registered dietitian. Counseling sessions occur throughout the 16 weeks and include nutrition education, goal setting, and practical strategies for following a Mediterranean-style diet. Participants will also complete a cooking education session and receive written program materials.
Participants will receive some food support, including Mediterranean pantry staples such as olive oil, herbs, and spices, as well as prepared meals delivered during the study. Food allergies, intolerances, and dietary restrictions will be reviewed before food is provided.
Participants will complete brief questionnaires during the study and additional study activities at the beginning and end. These visits may include health measurements and collection of blood, urine, saliva, stool, and skin swab samples.
At the end of the study, participants will also have an opportunity to provide feedback about their experience with the program.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a 16-week Mediterranean-pattern dietary intervention consisting of individualized dietary counseling, a cooking education module, Mediterranean food support, and printed educational materials. Participants complete in-person study visits at baseline (Week 0) and Week 16, scheduled in conjunction with routine dermatology appointments when possible.
Behavioral: Mediterranean Diet Counseling · Other: Mediterranean Food Support
Participants receive a 16-week Mediterranean-pattern dietary counseling program delivered primarily by video call. Individual counseling is provided by dietetic students under the supervision of a registered dietitian. Six core sessions occur at Weeks 1, 2, 5, 8, 11, and 14, with five individualized adherence-support contacts at Weeks 3, 6, 9, 12, and 15. Core sessions cover vegetables and fruit; whole grains and legumes; nuts, oils, dressings, and spreads; beverages, desserts, and snacks; eating out and sodium; and fish, meat, poultry, dairy, and eggs. Sessions include progress review, nutrition education, collaborative goal setting, an action plan, and planning for the next contact. A group or recorded cooking education module is completed between Weeks 5 and 8. Printed materials include HS and nutrition summaries, the MSLP manual, and cookbook.
Also known as: MSLP
Participants receive Mediterranean-pattern food support during the 16-week intervention to facilitate implementation of the dietary recommendations. At the baseline study visit, participants receive selected Mediterranean pantry staples, including extra-virgin olive oil, herbs, and spices. Home-delivered prepared meals consistent with the intervention dietary pattern are also provided during the study period. Before food is provided, participants complete an allergy and food-intolerance screening. Dietary restrictions and preferences relevant to food provision are reviewed before subsequent deliveries. Receipt of pantry items and meal deliveries is documented, and participants are asked to report the amount of each delivered meal consumed.
Feasibility of Intervention Measure (FIM)
The Feasibility of Intervention Measure (FIM) is a four-item participant-reported measure of the perceived feasibility of the intervention. Each item is rated on a five-point Likert scale from 1 (completely disagree) to 5 (completely agree), and the four item scores are averaged to give a total score ranging from 1 to 5. Higher scores indicate greater perceived feasibility. Scores will be summarized among participants with available Week 16 responses.The number of participants contributing data will be reported, and missing Week 16 assessments will be reported as missing rather than treated as study exclusions.
Time frame: Week 16
Change in Mediterranean Diet Adherence Screener (MEDAS) Score
The Mediterranean Diet Adherence Screener (MEDAS) is a validated 14-item screener developed in the PREDIMED study. Twelve items address the frequency of consumption of specified foods and two address food consumption habits. Each item scores 1 when the Mediterranean-pattern criterion is met and 0 when it is not, resulting in a total score ranging from 0 to 14, with higher scores indicating greater adherence to the Mediterranean dietary pattern. The alcohol item is scored according to the original PREDIMED criterion; increasing alcohol intake is not a goal of the intervention, and a prespecified sensitivity analysis will repeat this outcome using the 13-item score with the alcohol item omitted. The outcome is calculated as the Week 16 MEDAS total score minus the Week 0 MEDAS total score and can range from -14 to +14; positive values indicate increased adherence, negative values indicate decreased adherence, and 0 indicates no change.
Time frame: Week 0 and Week 16
Acceptability of Intervention Measure (AIM)
The Acceptability of Intervention Measure (AIM) is a four-item participant-reported measure of the acceptability of the intervention. Each item is rated on a five-point Likert scale from 1 (completely disagree) to 5 (completely agree), and the four item scores are averaged to give a total score ranging from 1 to 5. Higher scores indicate greater acceptability. Scores will be summarized among participants with available Week 16 responses. The number of participants contributing data will be reported, and missing Week 16 assessments will be reported as missing rather than treated as study exclusions.
Time frame: Week 16
Plan to share: Yes — Deidentified individual participant data that underlie the results reported in this study will be shared beginning 9 months following article publication and continuing for 36 months, provided that the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.
Time frame: Beginning 9 months following article publication and continuing for 36 months.
Access criteria: Requesting investigators must have approved IRB, IEC, or REB and an executed data use/sharing agreement with the University of North Carolina at Chapel Hill.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Aug 2027, 11 months later.
Of 25 interventional studies with no phase under Hidradenitis Suppurativa, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill →