TCTR20210701004CompletedPhase 1
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
Faculty of Science, Chulalongkorn University0 sites60 target enrollmentStarted: July 1, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 60
Study Overview
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.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 Years to 40 Years (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
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