Study Evaluating the Efficacy of DOSE Formulations in Treating Melasma and Cutaneous Signs of Aging

NCT04137263 | Completed

• 1 other identifier: DOSE-2019-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to evaluate the efficacy, of D.O.S.E formulations in the treatment of melasma and cutaneous signs of aging.

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• Improvement of Melasma

  change in Investigator MoPASI score

  Baseline to Day 120

Study Arms (1)

Treatment

EXPERIMENTAL

Subjects will receive dose formulation for treatment of melasma

Other: DOSE formulation

Interventions

DOSE formulation OTHER

over-the-counter topical

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Females age 18-65, Fitzpatrick skin types I-VI 2. Mild to moderate melasma 3. Half of subjects with hypervascular melasma identified by Visia complexion analysis 4. Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedures.
• \. Willingness to abstain from any other procedures to the areas to be treated throughout the trial period.
• \. Willingness and ability to comply with protocol requirements, including adherence to photography and returning for follow-up visits.
• \. Women of childbearing potential willing to use an acceptable form of birth control during trial period.
• Hormonal contraception - pill, injection, implant, patch, vaginal ring, Intrauterine device
• Intrauterine coil
• Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
• Abstinence (If practicing abstinence must agree to use barrier method described above (c) if becomes sexually active).
• Vasectomized partner (Must agree to use barrier method described above (c) if becomes sexually active with an Un-Vasectomized partner).
• \. Female patients will be either of non-childbearing potential defined as: Having no uterus and/or both ovaries, postmenopausal (no menses for at least 12 months prior), or has had a bilateral tubal ligation at least 6 months prior to study enrollment.

You may not qualify if:

• \. Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial.
• \. Known hypersensitivity or allergy to the components of the study medication. 3. Concurrent enrollment in any study involving the use of investigational devices or drugs.
• \. Current smoker or history of smoking in the last five years. 5. Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.
• \. Presence of an active systemic or local skin disease that may affect treatment area.
• \. History of the following cosmetic treatments to the area(s) to be treated:
• Energy based device or laser procedure to the area within the past 6 months (Ultherapy, ablative and non-ablative laser, intense pulsed light, etc)
• Medium to deep chemical peels (e.g. TCA, Phenol) for 6 months or light chemical peels (e.g. Glycolic Acid \>20%) within the past 3 months; 8. History of using the following cosmetic, OTC or prescription medications:
• a. Topical glycolic acid (5% or greater) in the past 4 weeks. b. Topical or oral tranexamic acid within in the past 4 weeks (e.g. Lytera 2.0); c. Topical Retinoids (e.g. Rx tretinoin or OTC retinol) within the past four weeks; d. Topical hydroquinone within the past 4 weeks; e. Topical salicylic acid within the past 4 weeks; f. Topical or oral corticosteroids within the past 4 weeks; g. Other topical products intended to treat melasma within the past 4 weeks; 9. Individuals who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.
• \. Any planned surgical intervention to the treatment area for the duration of the trial 11. Any visible surface alteration to the treatment area that may interfere with evaluation, at investigator discretion 12. Any pre-existing medical condition that may interfere with study compliance or evaluation, at investigator discretion 13. Inability to comply with all study protocols and regulations 14. Current taking an immunosuppressant or applying a topical corticosteroid to the affected area

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead
• L'Oreal: collaborator

Study Sites (1)

Cosmetic Laser Dermatology

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Monica Boen, M.D.

  Cosmetic Laser Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 24, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 20, 2024

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)