NCT03153852

Brief Summary

Melasma is a common acquired disorder of hyperpigmentation characterized by irregular light brown to dark brown patches of hyperpigmentation commonly affecting the face. The trunk and arms are also occasionally involved .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2018

Typical duration for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

1.8 years

First QC Date

May 11, 2017

Last Update Submit

January 23, 2018

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

  • Melasma Area and Severity Index (MASI)

    MASI = .3A(D+H) \[forhead\] + .3A(D+H)\[right malar\] + .3A(D+H)\[left malar\] + .1A(D+H)\[chin\]; A = area, D = darkness, and H = homogeneity. Area is based on percentage of the region covered by melasma using a 1-6 scale. Darkness is determined on a 0-3 scale. Homogeneity is based on a 0-4 scale.

    The mean change from the baseline to week-12

Secondary Outcomes (2)

  • Evaluation of Photographs

    change from the baseline to week-12

  • Global satisfaction score

    change from the baseline to week-12

Study Arms (1)

Combined peeling agents

EXPERIMENTAL

Modified Jessner's solution will be applied on the right side and glycolic acid 70% on the other side of the face.trichloroacetic acid 20% will be applied in one uniform coat to both sides

Drug: Modified Jessner's solutionDrug: Glycolic acidDrug: Trichloroacetic acid

Interventions

Modified Jessner's solutionDRUG

Modified Jessner's solution will be applied on the right side until frosting

Also known as: Combined peel
Combined peeling agents
Glycolic acidDRUG

Glycolic acid 70% on the other side of the face, then it will be neutralized with water after 5 minutes

Also known as: Combined peel
Combined peeling agents
Trichloroacetic acidDRUG

Trichloroacetic acid 20% will be applied in one uniform coat to both sides of the face until frosting

Also known as: Combined peel
Combined peeling agents

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults \>18 years old.
  • Clinical diagnosis of melasma.
  • Mental capacity to give informed consent.

You may not qualify if:

  • Pregnant females and females on oral contraceptive pills.
  • Patients with a history of hypertrophic scars or keloids.
  • Patients with recurrent herpes infection.
  • Patients with unrealistic expectation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • Yalamanchili R, Shastry V, Betkerur J. Clinico-epidemiological Study and Quality of Life Assessment in Melasma. Indian J Dermatol. 2015 Sep-Oct;60(5):519. doi: 10.4103/0019-5154.164415.

    PMID: 26538717BACKGROUND

  • Perez MI. The stepwise approach to the treatment of melasma. Cutis. 2005 Apr;75(4):217-22.

    PMID: 15916218BACKGROUND

  • Javaheri SM, Handa S, Kaur I, Kumar B. Safety and efficacy of glycolic acid facial peel in Indian women with melasma. Int J Dermatol. 2001 May;40(5):354-7. doi: 10.1046/j.1365-4362.2001.01149.x.

    PMID: 11555002BACKGROUND

  • Molinar VE, Taylor SC, Pandya AG. What's new in objective assessment and treatment of facial hyperpigmentation? Dermatol Clin. 2014 Apr;32(2):123-35. doi: 10.1016/j.det.2013.12.008.

    PMID: 24679999BACKGROUND

  • Gupta AK, Gover MD, Nouri K, Taylor S. The treatment of melasma: a review of clinical trials. J Am Acad Dermatol. 2006 Dec;55(6):1048-65. doi: 10.1016/j.jaad.2006.02.009. Epub 2006 Sep 28.

    PMID: 17097400BACKGROUND

  • Rendon M, Berneburg M, Arellano I, Picardo M. Treatment of melasma. J Am Acad Dermatol. 2006 May;54(5 Suppl 2):S272-81. doi: 10.1016/j.jaad.2005.12.039.

    PMID: 16631968BACKGROUND

  • Clark E, Scerri L. Superficial and medium-depth chemical peels. Clin Dermatol. 2008 Mar-Apr;26(2):209-18. doi: 10.1016/j.clindermatol.2007.09.015.

    PMID: 18472062BACKGROUND

  • Perez-Bernal A, Munoz-Perez MA, Camacho F. Management of facial hyperpigmentation. Am J Clin Dermatol. 2000 Sep-Oct;1(5):261-8. doi: 10.2165/00128071-200001050-00001.

    PMID: 11702317BACKGROUND

  • Landau M. Chemical peels. Clin Dermatol. 2008 Mar-Apr;26(2):200-8. doi: 10.1016/j.clindermatol.2007.09.012.

    PMID: 18472061BACKGROUND

  • Khunger N; IADVL Task Force. Standard guidelines of care for chemical peels. Indian J Dermatol Venereol Leprol. 2008 Jan;74 Suppl:S5-12.

    PMID: 18688104BACKGROUND

  • Monheit GD. The Jessner's + TCA peel: a medium-depth chemical peel. J Dermatol Surg Oncol. 1989 Sep;15(9):945-50. doi: 10.1111/j.1524-4725.1989.tb03181.x.

    PMID: 2778184BACKGROUND

  • Monheit GD. Chemical peels. Skin Therapy Lett. 2004 Feb;9(2):6-11.

    PMID: 14749844BACKGROUND

  • Soliman MM, Ramadan SA, Bassiouny DA, Abdelmalek M. Combined trichloroacetic acid peel and topical ascorbic acid versus trichloroacetic acid peel alone in the treatment of melasma: a comparative study. J Cosmet Dermatol. 2007 Jun;6(2):89-94. doi: 10.1111/j.1473-2165.2007.00302.x.

    PMID: 17524124BACKGROUND

  • Grimes PE. Melasma. Etiologic and therapeutic considerations. Arch Dermatol. 1995 Dec;131(12):1453-7. doi: 10.1001/archderm.131.12.1453.

    PMID: 7492140BACKGROUND

MeSH Terms

Conditions

Melanosis

Interventions

glycolic acidTrichloroacetic Acid

Condition Hierarchy (Ancestors)

HyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ChloroacetatesAcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydrocarbons, ChlorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Ereny Ramsis, Master

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ensaf Abdel-Maguid, MD

CONTACT

01005263721amiraali21@yahoo.com

Amira Ali, MD

CONTACT

01005263721amiraali21@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 15, 2017

Study Start

March 15, 2018

Primary Completion

December 15, 2019

Study Completion

December 15, 2020

Last Updated

January 25, 2018

Record last verified: 2018-01