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RosaceaPhase 1GabapentiNCT06776445

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

A Phase 1 study testing minocycline combined with hydroxychloroquine, gabapentin 300mg bid and gabapentin 300mg tid in people with Rosacea and Rosacea Subtype 1 (Erythematotelangiectatic), run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 60 years
What is being tested?
minocycline combined with hydroxychloroquine, gabapentin 300mg bid and gabapentin 300mg tid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
5 Jan 2024to 31 Jul 2025
Phase
Phase 1
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 12 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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 Informed consent was signed before treatment, and the clinical data were agreed to be used for scientific research

Who cannot join

  • ① received other treatment within 4 weeks of this treatment; ② facial flushing caused by other diseases and local irritation; ③ Patients with contraindication 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • First Affiliated Hospital of Chongqing Medical University

    Chongqing, 404100

Other trials in China

About this study

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
Being tested
minocycline combined with hydroxychloroquine, gabapentin 300mg bid, gabapentin 300mg tid
Keywords
rosacea
Medical subject headings
Rosacea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • minocycline combined with hydroxychloroquineDrug

    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

  • gabapentin 300mg bidDrug

    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

  • gabapentin 300mg tidDrug

    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

Study groups in NCT06776445
Study groupRoleWhat they receive
minocycline combined with hydroxychloroquineExperimentalNot described
Receives: Drug: minocycline combined with hydroxychloroquine
gabapentin 300mg bidActive comparatorNot described
Receives: Drug: gabapentin 300mg bid
gabapentin 300mg tidActive comparatorNot described
Receives: Drug: gabapentin 300mg tid

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 weeks, 8 weeks, 12 weeks after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2025
  2. Study start5 Jan 2024
  3. Primary completion31 Jul 2025
  4. Study completion31 Jul 2025

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06776445
Sponsor's protocol ID
2024MSXM069
Other IDs
CSTB2023NSCQ-MSX0078, 2024MSXM069
Acronym
Gabapenti
Status last verified
Dec 2025
First submitted
10 Jan 2025
Last updated
5 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing minocycline combined with hydroxychloroquine, gabapentin 300mg bid and gabapentin 300mg tid in people with Rosacea and Rosacea Subtype 1 (Erythematotelangiectatic), run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.

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 1 inclusion and 1 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 5 Jan 2026. 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 China. 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 phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

the score of CEA ( Clinician Erythema Assessment ) (time frame: 4 weeks, 8 weeks, 12 weeks after treatment). 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 NCT06776445, which also lists 8 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 5 Jan 2026.

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