The efficacy and safety of Delphini soothe and hydrate serum on acne counts and severity in acne/acneiform eruption induced by facial masks: a randomized double blind placebo-controlled trial
- Conditions
- Delphini soothe and hydrate serum, acne, acneiform eruption, facial maskacne/acneiform eruption induced by facial masks
- Registration Number
- TCTR20210701004
- Lead Sponsor
- Faculty of Science, Chulalongkorn University
- Brief Summary
In conclusion, we demonstrated the efficacy of the treatment product with AI complex in decreasing inflammatory lesions in maskne. The improvement was prominently displayed among the subgroups with concurrent maskne treatment. Besides, the data showed a favorable safety and tolerability profile, as reflected in a low rate of adverse effects after using the treatment product. The product may be a plausible adjunctive maskne treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
1. Both male and female participants aged 18-40 years with acne problems associated with wearing a mask by the following definitions:
a) No history of acne treatment: Acne worsening after at least 6 weeks of using mask and physical examination revealed acne on the mask-covered areas.
b) Being treated for acne: Acne breakouts after at least 6 weeks of using mask and physical examination revealed acne on the mask-covered areas.
2. Participants who were able to completely attend regular follow-up visits.
1. Participants who are pregnancy or lactating 2. Participants with a history of allergy to the components of the product. 3. Participants who applied corticosteroids in the area to be tested within 2 weeks, received oral or intravenous corticosteroids within 4 weeks before testing 4. Participants who were underwent facial aesthetic procedures such as filler injection, lasers in the area of treatment within 3 months 5. Participants with a history of herpes simplex infection and active dermatitis within 3 months or a history of skin cancer. 6. Participants with rash or other skin diseases on the face that interfered with the evaluation of acne, such as seborrheic dermatitis, rosacea, etc. 7. Participants with Fitzpatrick skin type V-VI.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method number of acne in each type week 0, 4, 8, 12 acne lesion counts,severity of acne week 0, 4, 8, 12 Leeds revised acne grading
- Secondary Outcome Measures
Name Time Method skin hydration week 0, 4, 8, 12 Corneometry,skin evaporation week 0, 4,8, 12 Transepidermal water loss ,sebum levels week 0, 4, 8, 12 sebumeter,post acne erythema week 0, 4, 8, 12 photography by camera and Visia ,patient satisfaction week 0, 4, 8, 12 Patient Satisfaction Scale (PSS) ,rate of adversed event reported week 0, 4, 8, 12 number of events