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

NCT06763367 | Not Yet Recruiting DMC

• 1 other identifier: KY20241217-04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Rosacea; Acne; Centella; Melasma

Outcome Measures

Primary Outcomes (3)

• Clinical erythema Score (CEA)

  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.

  Patients were followed up on the day of treatment and at 1, 2, 3, 4, 6, and 8 weeks after treatment.

• Global Aesthetic Improvement Scale Score (GAIS)

  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;

  Patients were followed up on the day of treatment and at 1, 2, 3, 4, 6, and 8 weeks after treatment.

• Melasma Area and Severity Rating (MASI)

  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.

  Patients were followed up on the day of treatment and at 1, 2, 3, 4, 6, and 8 weeks after treatment.

Secondary Outcomes (1)

• 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.

Study Arms (1)

Containing Centella sinensis mask group

EXPERIMENTAL

According to the random number table, both sides of the subjects' faces were randomly divided into the mask side and the control side (made of the same mask-like dressing), that is, one side of the face was applied with the Besuquan moisturizing repair mask, and the other side was applied with the control side. Patients were followed up on the day of treatment and 1, 2, 3, 4, 6 and 8 weeks after treatment. The specific methods are as follows: The patient applied 3 lobed membranes per week for the first month, and 2 pieces per week for 20 minutes each time for the second month.

Other: Face mask containing Centella sinensis

Interventions

Face mask containing Centella sinensis OTHER

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

Containing Centella sinensis mask group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Currently pregnant, planning to become pregnant or breastfeeding;
• Documented hypersensitivity to any active ingredient or excipient included in the study drug, or a history of adverse reactions to cosmetic products;
• Participate in other clinical studies within 3 months before the start of the study;
• Frequent use of Chinese medicine, sleeping pills, sedatives, anti-anxiety drugs or potentially addictive substances;
• 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;
• 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)
• Patients with incomplete observation data, incomplete course of treatment and inability to take drugs as prescribed by doctors were removed

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

MeSH Terms

Conditions

Rosacea; Acne Vulgaris; Melanosis

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Hyperpigmentation; Pigmentation Disorders

Central Study Contacts

jie dai

CONTACT

86-025-52271117; karry_dj@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nanjing First Hospital, Nanjing Medical University.

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: January 8, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 8, 2025

Record last verified: 2024-12

Locations

CN (1)