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Assessment of the safety and efficacy of 2GA16-containing cream in patients with atopic dermatitis

Assessment of the effectiveness of 2GA16-containing formulation for atopic dermatitis - Assessment of the effectiveness of 2GA16-containing formulation for atopic dermatitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000050130
Enrollment
30
Registered
2023-02-01
Start date
2023-02-06
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Atopic dermatitis

Interventions

Left-right comparison study (face) A group Left side: test cream Right side: 0.3% heparinoid-containing cream Each creams are applied twice daily for 11 weeks. Left-right comparison study (face)

Sponsors

Pias Corporation
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Japanese females between 20 and 59 years old with atopic dermatitis 2) Subjects with mild atopic dermatitis symptoms on the left and right sides of the face 3) Subjects who are currently undergoing treatment with topical agents, or who have had treatment after becoming an adult

Exclusion criteria

Exclusion criteria: 1) Those with atopic dermatitis who do not meet the selection criteria 2) Those who are taking systemic administration (oral or intravenous injection) of steroids, JAK inhibitors, biologics or immunosuppressant 3) Those who regularly use anti-inflammatory medications or antiallergic medications 4) Those who are undergoing PUVA therapy 5) Those who have undergone aesthetic medicine or special skin care treatments (peeling, hair removal treatment, etc.) within 4 weeks prior to the 0w test date, or those who plan to receive them during the test period. 6) Subjects who have been exposed to ultraviolet rays beyond their daily lives, such as working outdoors for long periods of time, exercising, swimming at the beach, or leisure activities within 4 weeks prior to the 0w test date, and those who have such a plan during the exam period 7) Those who work night shift or day and night shift 8) Those who are receiving treatment other than atopic dermatitis at a medical institution at the time of obtaining consent 9) Those who are a history of alcohol or drug dependence 10) Those who are likely to develop allergies to cosmetics and food (including those who have experienced skin abnormalities such as rashes due to cosmetics within the past year) 11) Those who have other serious underlying diseases 12) Those who are currently participating in other clinical trials, or those who have participated in clinical trials within the past 2 months 13) Women who are pregnant, planning to become pregnant, or breastfeeding 14) Those who have difficulty coming to the hospital on the specified date 15) In addition, those who are judged to be inappropriate for participation in this study by the principal investigator

Design outcomes

Primary

MeasureTime frame
Observation of skin findings and confirmation of adverse events by a dermatologist

Secondary

MeasureTime frame
Transepidermal water loss Stratum corneum water content Stratum corneum analysis Image analysis Patient questionnaires

Countries

Japan

Contacts

Public ContactShunya Sahara

Pias Corporation Central R&D Laboratory

ssahara@pias.co.jp078-992-6591

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026