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CompletedNCT06776445GabapentiUpdated Jan 5, 2026

Efficacy and Safety of Different Dose Regimens of Gabapentin for Treating Erythema/Flushing in Rosacea: A Randomized Controlled Trial

A Phase 1 interventional study of minocycline combined with hydroxychloroquine and gabapentin 300mg bid in Rosacea and Rosacea Subtype 1 (Erythematotelangiectatic), sponsored by First Affiliated Hospital of Chongqing Medical University. Completed at 1 site in China. Open to participants aged 12 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-01-05.

Sponsored by First Affiliated Hospital of Chongqing Medical University · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jan 2024, registered Jan 2025).
Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
12 Years to 60 Years
Sex
All
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Study summary

The goal of this clinical trial is to learn if Gabapentin works to treat flushing/erythema associated with rosacea. It will also learn about the safety of drug Gabapentin. The main questions it aims to answer are:

  • Does drug Gabapentin reduce flushing and erythema associated with rosacea?
  • What medical problems do participants have when taking drug Gabapentin? Researchers will compare Gabapentin to a positive control (minocycline plus hydroxychloroquine, a first-line treatment for rosacea) to see if drug Gabapentin works to reduce flushing and erythema associated with rosacea
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Conditions studied

  • Rosacea
  • Rosacea Subtype 1 (Erythematotelangiectatic)

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Keywords

  • rosacea
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In context

Rosacea

233 studies on the registry are indexed under Rosacea; 23 are open to participants now.

This study's enrollment of 50 is below the median of 61 across 200 interventional studies indexed under Rosacea.

Browse Rosacea studies →

Lead sponsor

First Affiliated Hospital of Chongqing Medical University is the lead sponsor of 95 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Initial treatment in our hospital; ② Diagnosed by two experienced dermatologists and in accordance with the updated diagnostic criteria of the National Rosacea Society (NRS) Expert Committee [38], unconscious disorder and no communication disorder; ③ did not receive any other form of treatment within 4 weeks; ④ Patients who were followed up for 8 weeks or more and had complete clinical data; ⑤ was signed before treatment, and the clinical data were agreed to be used for scientific research

Exclusion criteria

Exclusion Criteria:

① received other treatment within 4 weeks of this treatment; ② facial flushing caused by other diseases and local irritation; ③ Patients with to minocycline, hydroxychloroquine, gabapentin and carvedilol; ④ Unable to complete follow-up and serum specimen collection; ○5 patients were intolerant to minocycline, hydroxychloroquine and carvedilol; ○6 Lactation, pregnancy, liver and kidney dysfunction, psychiatric diseases, cardiovascular and cerebrovascular diseases, systemic lupus erythematosus and other systemic diseases.

Terms in these criteria, in plain language(2)

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.

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    minocycline combined with hydroxychloroquine

    Drug: minocycline combined with hydroxychloroquine

  • Active comparator
    gabapentin 300mg bid

    Drug: gabapentin 300mg bid

  • Active comparator
    gabapentin 300mg tid

    Drug: gabapentin 300mg tid

Interventions

  • Drugminocycline combined with hydroxychloroquine

    Drug pages: Minocycline · Hydroxychloroquine

    Patients with rosacea were collected and randomly divided into three groups for treatment, one group was treated with minocycline combined with hydroxychloroquine, one group was treated with gabapentin 300mg Bid, and the other group was treated with gabapentin 300mg tid. Before treatment, 4 weeks after treatment, and 8 weeks after treatment, the patient's condition score was statistically analyzed, and the efficacy and difference of each group were observed

  • Patients with rosacea were collected and randomly divided into three groups for treatment, one group was treated with minocycline combined with hydroxychloroquine, one group was treated with gabapentin 300mg Bid, and the other group was treated with gabapentin 300mg tid. Before treatment, 4 weeks after treatment, and 8 weeks after treatment, the patient's condition score was statistically analyzed, and the efficacy and difference of each group were observed

  • Patients with rosacea were collected and randomly divided into three groups for treatment, one group was treated with minocycline combined with hydroxychloroquine, one group was treated with gabapentin 300mg Bid, and the other group was treated with gabapentin 300mg tid. Before treatment, 4 weeks after treatment, and 8 weeks after treatment, the patient's condition score was statistically analyzed, and the efficacy and difference of each group were observed

06

What researchers measure

Primary outcomes

  1. the score of CEA ( Clinician Erythema Assessment )

    The reduction of the CEA score was compared before treatment, 4 weeks and 8 weeks, 12 weeks after treatment. The CEA score was assessed by a scale, 0 = clear, 1= almost clear, 2 =Mild, 3= Moderate,4= Severe.

    Time frame: 4 weeks, 8 weeks, 12 weeks after treatment

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Study locations

1 site
  • First Affiliated Hospital of Chongqing Medical University
    Chongqing, 404100, China
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References and documents

Publications

  • Del Rosso JQ, Webster G, Weiss JS, Bhatia ND, Gold LS, Kircik L. Nonantibiotic Properties of Tetracyclines in Rosacea and Their Clinical Implications. J Clin Aesthet Dermatol. 2021 Aug;14(8):14-21. Epub 2021 Aug 1. PubMed 34840653 ↗
  • Ma G, Zhang Y, Gao Q, Yuan X, Zhou Z, Jian D, Zhao Z, Wang B, Li J. Gabapentin improves the flushing of rosacea, but not other rosacea symptoms or quality of life: Results from a multicenter, randomized, double-blind, placebo-controlled pilot study. J Am Acad Dermatol. 2025 Apr;92(4):920-922. doi: 10.1016/j.jaad.2024.12.003. Epub 2024 Dec 15. No abstract available. PubMed 39681269 ↗
  • Wei J, Wan M, Chen Q, Fu J, Yang L, Ni R, Ge L, Dan Y, Chen X, Kong M, Li L, Chen S, Yang S, Zhang L, Xia A, Tang L, Zhang Y, Zhang M, Song Z, Li J. Gabapentin is an efficacy treatment for facial flushing and erythema of erythematotelangiectatic rosacea: A randomized clinical noninferiority trial. J Am Acad Dermatol. 2025 Apr;92(4):927-930. doi: 10.1016/j.jaad.2024.12.011. Epub 2024 Dec 20. No abstract available. PubMed 39710117 ↗
  • Logger JGM, Olydam JI, Driessen RJB. Use of beta-blockers for rosacea-associated facial erythema and flushing: A systematic review and update on proposed mode of action. J Am Acad Dermatol. 2020 Oct;83(4):1088-1097. doi: 10.1016/j.jaad.2020.04.129. Epub 2020 Apr 29. PubMed 32360760 ↗
  • Husein-ElAhmed H, Steinhoff M. Evaluation of the efficacy of subantimicrobial dose doxycycline in rosacea: a systematic review of clinical trials and meta-analysis. J Dtsch Dermatol Ges. 2021 Jan;19(1):7-17. doi: 10.1111/ddg.14247. Epub 2020 Sep 28. PubMed 32989925 ↗
  • Clanner-Engelshofen BM, Bernhard D, Dargatz S, Flaig MJ, Gieler U, Kinberger M, Klovekorn W, Kuna AC, Lauchli S, Lehmann P, Nast A, Pleyer U, Schaller M, Schofer H, Steinhoff M, Schwennesen T, Werner RN, Zierhut M, Reinholz M. S2k guideline: Rosacea. J Dtsch Dermatol Ges. 2022 Aug;20(8):1147-1165. doi: 10.1111/ddg.14849. Epub 2022 Aug 5. PubMed 35929658 ↗
  • Tu KY, Jung CJ, Shih YH, Chang ALS. Therapeutic strategies focusing on immune dysregulation and neuroinflammation in rosacea. Front Immunol. 2024 Jul 29;15:1403798. doi: 10.3389/fimmu.2024.1403798. eCollection 2024. PubMed 39136023 ↗
  • Barakji YA, Ronnstad ATM, Christensen MO, Zachariae C, Wienholtz NKF, Halling AS, Maul JT, Thomsen SF, Egeberg A, Thyssen JP. Assessment of Frequency of Rosacea Subtypes in Patients With Rosacea: A Systematic Review and Meta-analysis. JAMA Dermatol. 2022 Jun 1;158(6):617-625. doi: 10.1001/jamadermatol.2022.0526. PubMed 35385049 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06776445
Lead sponsor
First Affiliated Hospital of Chongqing Medical University
Responsible party
Bin Wei (Director, First Affiliated Hospital of Chongqing Medical University) — Principal investigator
First posted
Jan 15, 2025
Start date
Jan 5, 2024
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025
Last update
Jan 5, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Minocycline · Hydroxychloroquine

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