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NCT Number: NCT06763367

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

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.

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Key information

Conditions

Rosacea Acne Acne Vulgaris Acneiform Eruptions Centella Hyperpigmentation Melanosis Melasma Pigmentation Disorders Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

6.No medication was used within 1 month

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Clinical erythema Score (CEA)

    Time frame: 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.

  2. Global Aesthetic Improvement Scale Score (GAIS)

    Time frame: 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;

  3. Melasma Area and Severity Rating (MASI)

    Time frame: 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 outcomes

  1. Dermatology Quality of Life Score (DLQI)

    Time frame: 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; '

Study contacts

Contact information is provided by the study sponsor or research team.

jie dai

CONTACT

[email protected]

86-025-52271117

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2025
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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