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Not yet recruitingNCT06763367Updated Jan 8, 2025

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

An interventional study of Face mask containing Centella sinensis in Rosacea, Acne and Centella, sponsored by Nanjing First Hospital, Nanjing Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-01-08.

Sponsored by Nanjing First Hospital, Nanjing Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

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.

02

Conditions studied

  • Rosacea
  • Acne
  • Centella
  • Melasma
03

In context

Rosacea

233 studies on the registry are indexed under Rosacea; 23 are open to participants now.

This study's planned enrollment of 30 is below the median of 61 across 200 interventional studies indexed under Rosacea.

Browse Rosacea studies →

Lead sponsor

Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 224 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. ; 5There were no significant cardiac, liver, kidney, gastrointestinal, neurological, psychiatric, or metabolic disorders

6.No medication was used within 1 month

Exclusion criteria

Exclusion Criteria:

  1. Currently pregnant, planning to become pregnant or breastfeeding;
  2. Documented to any active ingredient or 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Containing Centella sinensis mask group

    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

  • OtherFace 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

06

What researchers measure

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.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2025; primary completion for Nov 2026, 22 months later.

Of 42 interventional studies with no phase under Rosacea, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's planned 22 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 2, 2025
First posted
Jan 8, 2025
StartEst.
Jan 8, 2025
Primary completionEst.
Nov 30, 2026
CompletionEst.
Nov 30, 2026
Last update
Jan 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06763367
Responsible party
dai jie (Nanjing First Hospital, Nanjing Medical University., Nanjing First Hospital, Nanjing Medical University) — Principal investigator
First posted
Jan 8, 2025
Start date
Jan 8, 2025 (estimated)
Primary completion
Nov 30, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Jan 8, 2025

Study contacts

jie dai
Contact
karry_dj@126.com
86-025-52271117

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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