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Effect of whitening cream on melasma

Efficacy and safety assessment of Januluma cream for treatment of moderate to severe melasma . A single arm, phase II clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016121031288N2
Enrollment
20
Registered
2017-04-07
Start date
2016-12-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Melasma. Chloasma

Interventions

Approving the Januluma whitening cream on patient with moderate to severe melasma (single arm study ).
Treatment - Drugs
Approving the Januluma whitening cream on patient with moderate to severe melasma (single arm study )

Sponsors

Jarfandishan-e Navid-e Salamat (Janus) knowledge-based company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion : Case of moderate to severe melasma (MGSC>2); age range 18-50 (men or women); signed informed consent voluntarily and knowingly Exclusion :pregnancy or lactation? use of systemic corticosteroid, isotretinoin within 28 days prior to the study; use any light sensitive drug within 3 months prior to the study? Active skin disease at test area: rosacea, atrophy, acne, eczema; Use of topical lightening products like AHA ,BHA and retinoid component within 21 days prior to the study; Documented allergies to components of Januluma cream? Use of contraceptive or any hormonal drugs? History of laser treatment or dermabrasion or deep facial peels within the past 3 months

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Modified melasma severity index. Timepoint: Before intervention, one month later, two month after intervention. Method of measurement: mMASI.

Secondary

MeasureTime frame
Skin pH. Timepoint: before and after 4and 8 weeks. Method of measurement: MPA 580.;Skin sebum. Timepoint: Before and after 4and 8 weeks. Method of measurement: MPA 580.;Skin melanin and erythem. Timepoint: before and after 4 and 8 weeks. Method of measurement: MPA 580.;TEWL. Timepoint: before and after 4 and 8 weeks. Method of measurement: MPA 580.;Size and value of skin spot. Timepoint: before and after 4 and 8 weeks. Method of measurement: Visioface.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaman Ahmad Nasrollahi

Center For Research And Training In Skin Diseases And Leprosy

samannasrol@gmail.com+98 21 8897 7921

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026