Skip to content

Evaluation of NLC nanoparticles containing hydroquinone, tretinoin, and fluocinolone in the treatment of melasma

Evaluation of safety and efficacy of Nanostructured lipid carrier( NLC) nanoparticles containing hydroquinone, tretinoin, and fluocinolone compared with conventional formulation in the treatment of melasma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20161207031288N13
Enrollment
20
Registered
2022-07-11
Start date
2022-07-23
Completion date
Unknown
Last updated
2022-08-29

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

Conditions

melasma. Chloasma

Interventions

Intervention 1: Intervention group: use of Nanostructured lipid carrier( NLC) nanoparticles containing hydroquinone, tretinoin and fluosinolone made in lab, in patients with moderate to severe melasma

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 18 - 50 years old men and women Case of approximately symmetrical moderate to severe melasma (melasma global severity score(MGSC)>2) No topical and systemic treatment for melasma during the last 4 weeks Appropriate general health condition No change in life style during the study Signing the consent form of the candidate to participate in the study and the desire to attend regular follow-up courses

Exclusion criteria

Exclusion criteria: Pregnant people or those who plan to become pregnant during the study People with known allergies to any of the components of the cream History of using each of the mentioned compounds topically in the last 21 days: Corticosteroids, retinoid compounds, chemical peels, alpha hydroxy acid and beta hydroxy acid compounds History of systemic use of each of the mentioned compounds in the last 28 days: corticosteroids, tretinoin compounds, interferon types Patients with rosacea, skin atrophy, acne and eczema History of use of drugs that increase photosensitivity in the last 3 months People who have had laser skin peeling or microdermabrasion in the last 3 months If the doctor of the study determines that the volunteer is not appropriate for this study by some reaons

Design outcomes

Primary

MeasureTime frame
Modified melasma severity index. Timepoint: Before intervention, 4 weeks later, 8 weeks after intervention. Method of measurement: Using mMASI(modified Melasma Severity Index).

Secondary

MeasureTime frame
Skin pH. Timepoint: Before intervention, 4 weeks later, 8 weeks after intervention. Method of measurement: MPA 580.;Skin sebum. Timepoint: Before intervention, 4 weeks later, 8 weeks after intervention. Method of measurement: MPA 580.;Skin melanin and erythem. Timepoint: Before intervention, 4 weeks later, 8 weeks after intervention. Method of measurement: MPA 580.;Trance Epidermal Water Lost (TEWL). Timepoint: Before intervention, 4 weeks later, 8 weeks after intervention. Method of measurement: MPA 580.;Size and value of skin spot. Timepoint: Before intervention, 4 weeks later, 8 weeks after intervention. Method of measurement: Visio face.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaman Ahmad Nasrollahi

Tehran University of Medical Sciences

samannasrol@gmail.com0098 21 8897 792

Outcome results

None listed

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