Clinical trial NCT06763367: Clinical Evaluation and Study of the Efficacy of a Centella Asiatica-Infused Facial Mask on Discosmetic Dermatosis
Official title: Clinical Evaluation and Study of the Efficacy of a Centella Asiatica-Infused Facial Mask on Discosmetic Dermatosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rosacea
Acne
Centella
Melasma
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to investigate the efficacy and safety of repairing facial mask containing Asiaticum asiatica in treating disjunctive skin diseases. A multi-center randomized double-blind self-half face control method was used. A computer-generated randomization method was used. Each cheek was randomly assigned to receive the snow glycoside mask and the control group.


Eligibility criteria: Inclusion Criteria:

1. Meet mild to moderate rosacea, acne diagnostic criteria; Meet the diagnostic criteria for melasma;
2. Over 18 years of age;
3. Be able to follow the treatment rules of the study and be followed for 8 weeks;
4. Informed consent; 5There were no significant cardiac, liver, kidney, gastrointestinal, neurological, psychiatric, or metabolic disorders

6.No medication was used within 1 month

Exclusion Criteria:

1. Currently pregnant, planning to become pregnant or breastfeeding;
2. Documented hypersensitivity to any active ingredient or excipient included in the study drug, or a history of adverse reactions to cosmetic products;
3. Participate in other clinical studies within 3 months before the start of the study;
4. Frequent use of Chinese medicine, sleeping pills, sedatives, anti-anxiety drugs or potentially addictive substances;
5. Present with concomitant skin conditions that may confuse the clinical assessment of rosacea, melasma, seborrheic dermatitis or pose a risk to participants, or have a history of severe skin conditions;
6. Normal use of relevant treatment (including intense pulsed light, pulsed fuel laser, oral and topical tranexamic acid, oral tetracycline antibiotics, oral compound glycyrrhizin and other anti-inflammatory drugs)
7. Patients with incomplete observation data, incomplete course of treatment and inability to take drugs as prescribed by doctors were removed

Primary outcomes:
measure: Clinical erythema Score (CEA)
timeFrame: Patients were followed up on the day of treatment and at 1, 2, 3, 4, 6, and 8 weeks after treatment.
measure: Global Aesthetic Improvement Scale Score (GAIS)
timeFrame: Patients were followed up on the day of treatment and at 1, 2, 3, 4, 6, and 8 weeks after treatment.
measure: Melasma Area and Severity Rating (MASI)
timeFrame: Patients were followed up on the day of treatment and at 1, 2, 3, 4, 6, and 8 weeks after treatment.
Secondary outcomes:
measure: Dermatology Quality of Life Score (DLQI)
timeFrame: Patients were followed up on the day of treatment and at 1, 2, 3, 4, 6, and 8 weeks after treatment.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
References: