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Efficacy and safety of tazarotene betasone cream in the treatment of inflammatory lichen/keratotic dermatosis: a randomized, controlled study

Efficacy and safety of tazarotene betasone cream in the treatment of inflammatory lichen/keratotic dermatosis: a randomized, controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102080
Enrollment
Unknown
Registered
2025-05-08
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-12

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

Conditions

Inflammatory lichen/keratotic dermatoses (e.g. chronic eczema, neurodermatitis, amyloidosis)

Interventions

Tazarotene betasone cream group:Topical application of tazarotene betamethasone cream, twice daily.
Halometasone cream group:Topical application of halometasone cream, twice a day.

Sponsors

Xi'an Jiaotong University Second Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Be able to understand and follow the trial procedures, voluntarily participate in the trial and sign the informed consent form; 2. Age 18-65 years inclusive, male or female; 3. Patients diagnosed with chronic eczema, neurodermatitis, primary skin amyloidosis, total skin lesion area accounting for 2-8% of body surface area, and medical history >=3 months before screening, mild and moderate patients with stable disease judged by the investigator; 4. Target lesion (IGA) >=3 at screening and baseline visits; 5. The study doctor assessed that local lesions were suitable for treatment with tazarotene betasone; 6. Willing and able to follow scheduled visits, treatment plans, picture collection and other study procedures;

Exclusion criteria

Exclusion criteria: 1. Allergic to the investigational drug and related ingredients; 2. Pregnant, expectant or lactating women; 3. Lesions are only located in special parts such as head, face, vulva and other sensitive parts with rich hair or thin skin. 4. Bacterial, fungal and viral infections with skin lesions in acute phase or combined activities. 5. Patients with serious concomitant diseases at screening, requiring systemic hormone therapy or other intervention measures, affecting the evaluation of efficacy; 6. Those who have had or currently have serious respiratory system, cardiovascular and cerebrovascular diseases, liver, kidney, digestive tract, musculoskeletal diseases, genitourinary system, immunity, endocrine diseases (such as uncontrolled diabetes), metabolism, mental nerves and other diseases, which may affect the safety or result evaluation of the subjects according to the judgment of the investigator. 7. Use of biological agents within 3 months before enrollment; systemic use of JAK inhibitors, glucocorticoids, retinoids and immunosuppressants within the first 4 weeks; phototherapy within the first 4 weeks; use of systemic traditional Chinese medicines and Chinese patent medicines within the first 2 weeks; use of local treatment drugs such as topical corticosteroids (TCS), topical calcineurin inhibitors (TCI) and topical retinoids for target lesions within the first 1 week; 8. Any subject who, in the opinion of the investigator, is not suitable for participation in this clinical study;

Design outcomes

Primary

MeasureTime frame
Target lesion IGA(Investigators Global Assessment)0/1 achieve;

Secondary

MeasureTime frame
recurrence rate;Improvement from baseline in target lesions (hyperkeratosis, hypertrophy, lichenization);dermatology life quality index, DLQI;2-point decrease of Target lesion IGA;VAS;incidence of adverse reactions;

Countries

China

Contacts

Public ContactSongmei Geng

Xi'an Jiaotong University Second Affiliated Hospital

gengsongmei73@163.com+86 29 87679969

Outcome results

None listed

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