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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

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

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210701004
Enrollment
60
Registered
2021-07-01
Start date
2021-11-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acne/acneiform eruption induced by facial masks Delphini soothe and hydrate serum, acne, acneiform eruption, facial mask

Interventions

Apply Delphini soothe and hydrate serum on the face and neck twice daily for 12 weeks.,Apply placebo serum without active ingredients on the face and neck twice daily for 12 weeks.
Experimental Drug,Placebo Comparator Drug
Delphini soothe and hydrate serum ,placebo serum without active ingredients

Sponsors

Faculty of Science, Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactChanat Kumtornrut

Faculty of Medicine, Chulalongkorn university

Chanat035@gmail.com66814594965

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026