RosaceaNCT06763367
Clinical Evaluation and Study of the Efficacy of a Centella Asiatica-Infused Facial Mask on Discosmetic Dermatosis
A study testing Face mask containing Centella sinensis in people with Rosacea and Acne, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- What is being tested?
- Face mask containing Centella sinensis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanjing First Hospital
Nanjing, Jiangsu, 210006
jie dai, 86-025-52271117, karry_dj@126.com
About this study
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.
- Being tested
- Face mask containing Centella sinensis
- Medical subject headings
- Rosacea, Acne Vulgaris, Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face mask containing Centella sinensisOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Face mask containing Centella sinensis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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;
Measured: 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.
Measured: 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; '
Measured: Patients were followed up on the day of treatment and at 1, 2, 3, 4, 6, and 8 weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start8 Jan 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dai jie, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763367
- Sponsor's protocol ID
- KY20241217-04
- Status last verified
- Dec 2024
- First submitted
- 2 Jan 2025
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation and Study of the Efficacy of a Centella Asiatica-Infused Facial Mask on Discosmetic Dermatosis
- ClinicalTrials.gov ID
- NCT06763367
- Acronym / sponsor ID
- KY20241217-04
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 8 Jan 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Containing Centella sinensis mask group | Experimental | Other: Face mask containing Centella sinensisAccording 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face mask containing Centella sinensisA 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 | Other | Containing Centella sinensis mask group |
Primary outcome
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.
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;
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face mask containing Centella sinensis in people with Rosacea and Acne, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jie dai (86-025-52271117, karry_dj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025; AzTrials last refreshed its copy on 26 Oct 2026.