Clinical Trials in China / NCT06763367
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Clinical Evaluation and Study of the Efficacy of a Centella Asiatica-Infused Facial Mask on Discosmetic Dermatosis
NCT06763367 · tracked via the Priya Life Science China tracker
Condition(s) studied
RosaceaAcneCentellaMelasma
Investigational drug(s) / intervention(s)
Face mask containing Centella sinensis
Face mask containing Centella sinensis: A half-face control test was used in this study. One side of the face was treated with a mask containing Asiaticum asiatica and the other side was treated with a mask without Asiaticum asiatica
Study 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
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 outcome measure(s)
- Clinical erythema Score (CEA) — Patients were followed up on the day of treatment and at 1, 2, 3, 4, 6, and 8 weeks after treatment.
Clinical erythema score (CEA) was divided into no, mild, moderate and severe according to the severity of rosacea, corresponding to 0,1,2,3, respectively. - Global Aesthetic Improvement Scale Score (GAIS) — Patients were followed up on the day of treatment and at 1, 2, 3, 4, 6, and 8 weeks after treatment.
The Global Aesthetic Improvement Scale (GAIS) score was evaluated by the treating physician and divided into four levels: very improved corresponding, substantial improvement, improvement, no change; Corresponding to the best beauty effect, significant improvement but not the best, significant improvement, no change; - Melasma Area and Severity Rating (MASI) — Patients were followed up on the day of treatment and at 1, 2, 3, 4, 6, and 8 weeks after treatment.
The melasma Area and Severity Rating (MASI) is used to evaluate the severity of melasma. Melanin deposition was quantitatively evaluated from three aspects: area, color depth and color uniformity. Area weight: Forehead 30%, left cheek 30%, right cheek 30%, mandibular 10%, color plaque proportion (A) \< 10% recorded 1 points, 10% \~ 29% recorded 2 points, 30% \~ 49% recorded 3 points, 50% \~ 69% recorded 4 points, 70% \~ 89% recorded 5 points, 90% \~ 100% recorded 6 points; Color depth (D), color uniformity (H) scores range from 0 to 4 points, no score 0 points, slight score 1 points, moderate score 2 points, obvious score 3 points, maximum score 4 points. MASI score = forehead \[0.3A (D+H)\]+ right cheek \[0.3A (D+H)\]+ left cheek \[0.3A (D+H)\]+ mandibular \[0.1A (D+H)\], score range 0 \~ 48, score was positively correlated with melanin deposition.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Nanjing First Hospital | Nanjing | Jiangsu |
More Nanjing First Hospital, Nanjing Medical University trials in China
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06763367 on ClinicalTrials.gov ↗ ← All trials in China