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Efficacy and safety of gabapentin in the treatment of erythema telangiectasia rosacea: a non-inferior randomized controlled study

Efficacy and safety of gabapentin in the treatment of erythema telangiectasia rosacea: a non-inferior randomized controlled study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076342
Enrollment
Unknown
Registered
2023-10-05
Start date
2023-10-07
Completion date
Unknown
Last updated
2023-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rosacea

Interventions

Carvedilol: oral carvedilol 5 mg twice per day
Gabapentin:oral gabapentin 300 mg thrice per day

Sponsors

Dermatology Department, Southwest Hospital, Third Military Medical University, Chongqing, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: (1). Patients aged fron 18 to 40 years old (including 18 years old and 40 years old, regardless of gender) (2). In line with the diagnostic criteria of ETR, the main manifestations are recurrent flushing and persistent erythema of the facial skin. (3). A variety of inducing factors aggravated the clinical symptoms of patients, including temperature change, sun exposure, spicy stimulating food, topical drugs, mental factors and so on. (4). Ability to follow study or follow-up procedures and collaborate to observe adverse events and outcomes (5). Written informed consent signed by the patient or his/her guardian.

Exclusion criteria

Exclusion criteria: (1) Patients who were allergic to carvedilol or gabapentin. (2) Patients with bronchial asthma or hypotension and bradycardia. (3) Participated in the clinical study of any investigational drug within 1 month before enrollment. (4) Medications that affect rosacea symptoms, such as retinoids, are being used. (5) Patients with serious heart, liver, lung, kidney and other organ diseases and hematopoietic system diseases that researchers consider unsuitable for clinical trials. (6) Patients with malignant tumors or immunosuppression. (7) patients with acne, atopic dermatitis, hormone-dependent dermatitis and other facial skin diseases. (8) patient has a history of sun exposuren in the past month. (9) patients with drug, tobacco and alcohol addiction. (10) Pregnant or lactating women and those planning to pregnant within one year. (11) Inability or unwillingness to cooperate due to mental or neurological disorders. (12) Patients with bradycardia. (13) Patients with hypotension. (14) Patients with papulopustular rosacea (PPR), phymatous rosacea (PHY), and ocular rosacea (OR).

Design outcomes

Primary

MeasureTime frame
clinician’s Erythema Assessment (CEA);

Secondary

MeasureTime frame
Patient Self-Assessment (PSA);flushing severity scale (GFSS);Pittsburgh Sleep Quality Index (PSQI);Visual Analogue Scale for migraine (VAS);Generalized Anxiety Disorder-7 (GAD-7) ;Patient Health Questionnaire-9 (PHD-9);

Countries

China

Contacts

Public ContactJian Li

Dermatology Department, Southwest Hospital, Third Military Medical University, Chongqing, China

ljian0630@163.com+86 150 8665 2137

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026