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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNanjing First Hospital, Nanjing Medical University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Face mask containing Centella sinensis

    Other intervention

    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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Containing Centella sinensis mask groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

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

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;

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

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.

Time frame
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)

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; '

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: