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A non-inferior randomized controlled study on the efficacy and safety of daylight photodynamic therapy (DL-PDT) for papulopustular rosacea(PPR)

A non-inferior randomized controlled study on the efficacy and safety of daylight photodynamic therapy (DL-PDT) for papulopustular rosacea(PPR)

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076423
Enrollment
Unknown
Registered
2023-10-08
Start date
2023-10-09
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

Daylight photodynamic therapy (DL-PDT) :DL-PDT treatment with 10% ALA was performed 4 times, each treatment interval of 2 weeks (14 days).
Conventional photodynamic therapy (c-PDT) :C-PDT treatment with 10% ALA was performed 4 times, each treatment interval of 2 weeks (14 days).
minocycline hydrochloride:Oral minocycline hydrochloride (50mg/ night) for 6 weeks (42 days)

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 PPR. (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). Not pregnant in woman patients. (5). Written informed consent signed by the patient or his/her guardian.

Exclusion criteria

Exclusion criteria: (1) People who are allergic to porphyrins and minocycline hydrochloride, have a history of photosensitivity. (2) Participated in the clinical study of any investigational drug within 1 month before enrollment. (3) Topical antibiotics, retinoids, corticosteroids, peroxybenzoyl and other drugs affecting rosacea symptoms had been used within 1 month before treatment; (4) Patients with serious heart, liver, lung, kidney and other organ diseases and hematopoietic system diseases that researchers consider unsuitable for clinical trials. (5) Patients with malignant tumors or immunosuppression. (6) patients with acne, atopic dermatitis, hormone-dependent dermatitis and other facial skin diseases. (7) History of surgery in the past six months and exposure to blazing sun in the past month; (8) Have a history of HIV infection or HIV antibody positive, and have a history of HSV attack in the last three months at the treatment site; (9) Patients with drug, tobacco and alcohol addiction. (10) mental or neurological disorders. (11) Pregnant or lactating women and those planning to pregnant within one year. (12) Received photoelectric therapy in the past three months. (13) Patients with more than 2 kinds of heart, lung, liver, kidney complications. (14) Patients withbronchial asthma, hypotension or bradycardia.ETR (15) Patients with erythema telangiectasia rosacea (ETR), phymatous rosacea (PHY), and ocular rosacea (OR).

Design outcomes

Primary

MeasureTime frame
investigator’s global assessment;

Secondary

MeasureTime frame
skin lesion scores;The rosacea-specific Qol instrument;clinician’s Erythema Assessment (CEA);Test of facial Dermatoscope;Test of facial invivo reflectance confocal microscopy;

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