Clinical Evaluation and Study of the Efficacy of a Centella Asiatica-Infused Facial Mask on Discosmetic Dermatosis

Not Applicable

Not yet recruiting

• Conditions: Rosacea; Acne; Centella; Melasma

• Registration Number: NCT06763367
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-02
• Last Update Submitted: 2025-01-02
• Study Start: 2025-01-08
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Dermatology Quality of Life Score (DLQI)	Patients were followed up on the day of treatment and at 1, 2, 3, 4, 6, and 8 weeks after treatment.	The Dermatology Life Quality Score (DLQI) is scored by answering multiple questions in which patients self-rate the impact of their current illness on their lives over a period of one week. The answer is divided into four levels, very serious 3 points, severe 2 points, a little 1 point, no 0 points; '

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China