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Gabapentin Alone and in Combination With Carvedilol for the Treatment of Rosacea-Associated Flushing and Erythema:a Randomized Controlled Clinical Trial

C

Chongqing Medical University

Status and phase

Completed
Phase 1

Conditions

Rosacea Subtype 1 (Erythematotelangiectatic)
Rosacea

Treatments

Drug: gabapentin 300mg bid
Drug: gabapentin 300mg tid
Drug: minocycline combined with hydroxychloroquine

Study type

Interventional

Funder types

Other

Identifiers

NCT06776445
2024MSXM069
CSTB2023NSCQ-MSX0078 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment

50 patients

Sex

All

Ages

12 to 60 years old

Volunteers

No Healthy Volunteers

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

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 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

50 participants in 3 patient groups

minocycline combined with hydroxychloroquine
Experimental group
Treatment:
Drug: minocycline combined with hydroxychloroquine
gabapentin 300mg bid
Active Comparator group
Treatment:
Drug: gabapentin 300mg bid
gabapentin 300mg tid
Active Comparator group
Treatment:
Drug: gabapentin 300mg tid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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